<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488861</url>
  </required_header>
  <id_info>
    <org_study_id>NHS001747 V2.0</org_study_id>
    <nct_id>NCT04488861</nct_id>
  </id_info>
  <brief_title>The START Clinic: a Feasibility Study</brief_title>
  <acronym>START</acronym>
  <official_title>A Feasibility Study of a Translational Research Antenatal Clinic for IVF-conceived Pregnancies: The St Mary's After Reproductive Technology (START) Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester Academic Health Science Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academy of Medical Sciences, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tommy's</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester Academic Health Science Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of the feasibility of a translational research clinic for pregnancies&#xD;
      conceived by in vitro fertilisation (IVF). A group of at least 120 pregnancies (of which, at&#xD;
      least 80 IVF-conceived) will be followed from early pregnancy to delivery, in order to gain&#xD;
      early insights into the growth of the baby before birth, the physical and emotional&#xD;
      adaptation of the mother to the pregnancy and how the placenta works. The investigators will&#xD;
      collect preliminary data on how these factors may differ between pregnancies conceived with&#xD;
      and without IVF, and between different IVF treatment modalities such as fresh or &quot;frozen&quot;&#xD;
      embryo transfer IVF. The study aims to understand the practicalities of such a clinic, to&#xD;
      identify barriers to participation in the clinic, to assess the uptake of different research&#xD;
      measurements and to identify key measurements/time points with the greatest potential to&#xD;
      identify and understand the origin of fetal growth and maternal adaptation differences after&#xD;
      IVF conception in a full scale study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to test the feasibility of establishing the first&#xD;
      IVF-conceived pregnancy antenatal clinic specifically to collect longitudinal data relating&#xD;
      to the growth of the baby in the womb, how the mother's heart and blood vessels adapt to the&#xD;
      increased workload of pregnancy, and how the mother's emotional health (particularly stress&#xD;
      and anxiety) varies throughout pregnancy.&#xD;
&#xD;
      The feasibility of the study protocol will be assessed using stop/go (or progression)&#xD;
      criteria, to help determine whether future, larger scale studies of the same should be&#xD;
      commenced. The information gathered to answer the primary and secondary outcomes of the&#xD;
      study's primary objective will be essential for understanding, and overcoming, potential&#xD;
      barriers to recruitment to future cohort studies within the clinic. It will enable the&#xD;
      researchers to plan future studies with sufficient sample size to answer the specified&#xD;
      question, realistic recruitment targets and timescales to achieve this, and using&#xD;
      investigations that are shown to be acceptable to the majority of individuals in the target&#xD;
      population. The secondary objective of the study is to gather preliminary data relating to&#xD;
      the effects of fresh and frozen embryo transfer IVF on fetal, maternal and placental health.&#xD;
&#xD;
      The study is based on the design of several successful pregnancy cohort studies (such as the&#xD;
      Tommy's Project), which run through five translational research clinics in St. Mary's&#xD;
      Hospital, Manchester University Hospitals National Health Service (NHS) Foundation Trust:&#xD;
      VELOCITY clinic, Lupus in Pregnancy service, Manchester Placenta Clinic, Rainbow clinic and&#xD;
      Manchester Antenatal Vascular Service. The START clinic replicates the model of care offered&#xD;
      through these existing clinics, offering the same levels of specialised, continuity of care&#xD;
      to individuals who have conceived by IVF. These successful recruitment and retention within&#xD;
      these studies gives confidence in the acceptability of the study.&#xD;
&#xD;
      The study design is a cohort study. This is where individual participants can be divided into&#xD;
      groups by specified characteristics, in this case whether or not they had conceived by IVF or&#xD;
      not (or sub-categorised by individual factors within the IVF treatment process, such as&#xD;
      whether the embryo was transferred fresh or after a period of cryopreservation). No active&#xD;
      intervention (medicine or procedure) will be administered during the study. However, it is&#xD;
      known that health outcomes of individuals participating in research may be influenced by the&#xD;
      experience of participating in the study itself. For this reason the investigators will also&#xD;
      recruit &quot;control&quot; participants (those who have conceived without IVF, either spontaneously or&#xD;
      with medication to aid the release of eggs, known as ovulation induction). By comparing the&#xD;
      two groups, this will enable the research to isolate the specific effects of the&#xD;
      IVF-conception, from the effects of being highly monitored in a research study. The&#xD;
      investigators intend to recruit a minimum of 120 individuals across a period of three years,&#xD;
      with approximately 4 individuals who have conceived by IVF to every 1 individual who has&#xD;
      conceived without IVF.&#xD;
&#xD;
      Appointments in the START clinic will be arranged roughly 4-6 weekly (at approximately 9, 17,&#xD;
      23, 28, 33, 37 and 41 weeks). At each appointment the patient will be reviewed by a doctor&#xD;
      and midwife from a small team of clinicians who will provide continuity of care. Routine&#xD;
      scheduled antenatal care will be performed, along with additional measurements of fetal and&#xD;
      placental growth and cardiovascular function, questionnaires relating to environmental&#xD;
      exposures, modifiable risks, and emotional health, and samples of maternal blood, urine,&#xD;
      saliva and hair. More frequent appointments will be scheduled according to local hospital&#xD;
      guidance if complications of pregnancy are suspected or confirmed, this may mean that&#xD;
      clinical measurements and ultrasound examinations are performed more frequently than at the&#xD;
      planned study visits. Questionnaires and biological samples will only be&#xD;
      administered/obtained at the (study visit closest to) stated gestational intervals.&#xD;
      Participants will be made aware of which measurements are part of standard antenatal care and&#xD;
      which investigations are for research; research measurements will be analysed blinded to&#xD;
      participant identity/pregnancy outcome after conclusion of the pregnancy and will not&#xD;
      contribute to their care during or after the pregnancy. Participants can decline particular&#xD;
      investigations entirely or on occasion without detriment to their overall care. Where&#xD;
      necessary, according to the individual needs of the participant, antenatal care will be&#xD;
      shared with community midwives and other antenatal services where additional appointments are&#xD;
      required outside the stated schedule.&#xD;
&#xD;
      At birth, the placenta and fetal blood contained within it after clamping of the umbilical&#xD;
      cord, will be collected. Placental tissue may be used immediately after birth in experiments&#xD;
      to study how it functions, or small amounts may be processed and stored (according to local&#xD;
      standard operating procedures) for later assessment of its structure and functional&#xD;
      footprint. Should histopathological examination of the placenta be indicated for clinical&#xD;
      reasons (&lt;5% of all pregnancies), the remaining placental tissue will be made available for&#xD;
      this purpose according to standard local protocols for combined research and&#xD;
      histopathological placental examination; otherwise unused placental tissue will be disposed&#xD;
      sensitively according to local National Health Service procedures. Prior to discharge from&#xD;
      the hospital, and preferably within 3 days of birth, the baby will be measured (using a tape&#xD;
      measure) once for head, abdominal and thigh circumference, and length. Their skinfold&#xD;
      thickness (to measure fat depth) over the shoulder blade and under the upper arm will be&#xD;
      measured using purpose-built callipers. The baby will be kept warm and comfortable&#xD;
      throughout, and the examination paused or stopped should the baby show distress, need feeding&#xD;
      or changing or any medical intervention be required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 15, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment feasibility: Number of referrals received</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment feasibility: Proportion of referrals eligible for recruitment</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment feasibility: Proportion of eligible individuals accepting recruitment</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment feasibility: Rate of recruitment</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment feasibility: Gestation at referral/first appointment</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment feasibility: Rate of consent to contact for future studies involving mother or child</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Proportion of recruits completing all study visits</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Average number of study visits required by each individual</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Proportion of individuals accepting each type/gestation of investigation</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Reliability of each type/gestation of investigation</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Rate of withdrawal / loss to follow up</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol feasibility: Proportion of recruits where fertility records could be accessed</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Missing data: Proportion of recruits scanned before 12 weeks' gestation</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Missing data: Proportion of missing data points for each type/gestation of investigation</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Missing data: Proportion of fertility treatment variables that could be ascertained from fertility records</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>IVF</condition>
  <condition>Fetal Growth Retardation</condition>
  <condition>Preeclampsia</condition>
  <condition>Placenta Diseases</condition>
  <arm_group>
    <arm_group_label>IVF-conceived</arm_group_label>
    <description>Those who have conceived by IVF (for whatever indication); target 80 participants of which it is anticipated 20 would have conceived by frozen embryo transfer IVF.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spontaneously conceived</arm_group_label>
    <description>Those who have conceived spontaneously (within 12 months and without use of hormonal or other contraception); target 20 participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ovulation induction-conceived</arm_group_label>
    <description>Those who have conceived by ovulation induction (after more than 12 months); target 20 participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional cohort study</intervention_name>
    <description>Non-interventional cohort study</description>
    <arm_group_label>IVF-conceived</arm_group_label>
    <arm_group_label>Ovulation induction-conceived</arm_group_label>
    <arm_group_label>Spontaneously conceived</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal blood (pre-delivery) Maternal urine Maternal saliva Maternal hair Placental tissue&#xD;
      Umbilical cord blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant individuals, meeting the inclusion and exclusion criteria, registering for&#xD;
        antenatal care and delivery at Manchester University Hospitals NHS Foundation Trust.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Maternal age at enrolment of between 18 -39 years&#xD;
&#xD;
          2. (Current pregnancy) Conception by IVF, or spontaneously (&quot;naturally&quot;) within 12 months&#xD;
             of trying to conceive, or with medication to stimulate egg release (ovulation&#xD;
             induction) after a delay in conceiving of more than 12 months&#xD;
&#xD;
          3. Antenatal care and delivery planned at St. Mary's Hospital, Manchester&#xD;
&#xD;
          4. Pregnant with one, live baby within the womb (known medically as a singleton, viable,&#xD;
             intrauterine pregnancy) at the time of recruitment&#xD;
&#xD;
          5. Able to give informed consent, with or without the use of interpretation services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prisoners&#xD;
&#xD;
          2. Maternal age at enrolment younger than 18 or greater than or equal to 40 years.&#xD;
&#xD;
          3. Conception in current pregnancy by non-IVF, non-Intra Cytoplasmic Sperm Injection&#xD;
             fertility treatment (e.g. intrauterine insemination, intracervical insemination,&#xD;
             gamete or zygote intrafallopian transfer), ovulation induction without delay in&#xD;
             conception of at least 12 months' duration, or spontaneous conception after a delay in&#xD;
             conception of more than 12 months, or during use of (regular or emergency hormonal or&#xD;
             intrauterine) contraception. Conception following condom failure without emergency&#xD;
             hormonal contraception use is not an exclusion criteria.&#xD;
&#xD;
          4. Potential participant or partner not willing to consent to disclosure of fertility&#xD;
             treatment records to the research team&#xD;
&#xD;
          5. Antenatal care and delivery planned at another hospital&#xD;
&#xD;
          6. Pre-existing maternal medical condition requiring specialist antenatal care beyond the&#xD;
             scope of the SMART clinic, including BMI &gt; 35, pre-existing diabetes and hypertension&#xD;
&#xD;
          7. Miscarriage or fetal death in utero at the point of recruitment&#xD;
&#xD;
          8. Presence of detected clinically significant (as defined by clinician in charge of&#xD;
             care) fetal abnormalities&#xD;
&#xD;
          9. Refusal of consent, including consent of the participant and any partner to access to&#xD;
             fertility treatment records (as applicable)&#xD;
&#xD;
         10. Language barrier not overcome by telephone or video interpretation services&#xD;
&#xD;
         11. Lack of capacity to consent despite detailed explanation, ample opportunity to ask&#xD;
             questions and time to consider options&#xD;
&#xD;
         12. Transfer of care to another hospital out of area&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lucy Higgins, PhD MRCOG</last_name>
    <phone>+441617016957</phone>
    <email>lucy.higgins@manchester.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ed Johnstone, PhD MRCOG</last_name>
    <email>edward.johnstone@manchester.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maternal and Fetal Health Research Centre, University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucy Higgins, PhD MBChB MRCOG</last_name>
      <email>lucy.higgins@manchester.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Manchester Academic Health Science Centre</investigator_affiliation>
    <investigator_full_name>Lucy Higgins</investigator_full_name>
    <investigator_title>NIHR Academic Clinical Lecturer in Obstetrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Placenta Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of the study findings and complete anonymisation of the data, individual patient data will be deposited in an online data repository such as Mendeley Data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>3 to 5 years</ipd_time_frame>
    <ipd_access_criteria>Open access for completely anonymised data with appropriate metadata for interpretation. Applications to access pseudonymised data may be considered in writing to the principal investigator, subject to appropriate local approvals and a data management plan that conforms to the requirements of the University of Manchester.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488861
org study id: NHS001747 V2.0
nct id: NCT04488861
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study of the feasibility of a translational research clinic for pregnancies
      conceived by in vitro fertilisation (IVF). A group of at least 120 pregnancies (of which, at
      least 80 IVF-conceived) will be followed from early pregnancy to delivery, in order to gain
      early insights into the growth of the baby before birth, the physical and emotional
      adaptation of the mother to the pregnancy and how the placenta works. The investigators will
      collect preliminary data on how these factors may differ between pregnancies conceived with
      and without IVF, and between different IVF treatment modalities such as fresh or "frozen"
      embryo transfer IVF. The study aims to understand the practicalities of such a clinic, to
      identify barriers to participation in the clinic, to assess the uptake of different research
      measurements and to identify key measurements/time points with the greatest potential to
      identify and understand the origin of fetal growth and maternal adaptation differences after
      IVF conception in a full scale study.
The primary objective of the study is to test the feasibility of establishing the first
      IVF-conceived pregnancy antenatal clinic specifically to collect longitudinal data relating
      to the growth of the baby in the womb, how the mother's heart and blood vessels adapt to the
      increased workload of pregnancy, and how the mother's emotional health (particularly stress
      and anxiety) varies throughout pregnancy.

      The feasibility of the study protocol will be assessed using stop/go (or progression)
      criteria, to help determine whether future, larger scale studies of the same should be
      commenced. The information gathered to answer the primary and secondary outcomes of the
      study's primary objective will be essential for understanding, and overcoming, potential
      barriers to recruitment to future cohort studies within the clinic. It will enable the
      researchers to plan future studies with sufficient sample size to answer the specified
      question, realistic recruitment targets and timescales to achieve this, and using
      investigations that are shown to be acceptable to the majority of individuals in the target
      population. The secondary objective of the study is to gather preliminary data relating to
      the effects of fresh and frozen embryo transfer IVF on fetal, maternal and placental health.

      The study is based on the design of several successful pregnancy cohort studies (such as the
      Tommy's Project), which run through five translational research clinics in St. Mary's
      Hospital, Manchester University Hospitals National Health Service (NHS) Foundation Trust:
      VELOCITY clinic, Lupus in Pregnancy service, Manchester Placenta Clinic, Rainbow clinic and
      Manchester Antenatal Vascular Service. The START clinic replicates the model of care offered
      through these existing clinics, offering the same levels of specialised, continuity of care
      to individuals who have conceived by IVF. These successful recruitment and retention within
      these studies gives confidence in the acceptability of the study.

      The study design is a cohort study. This is where individual participants can be divided into
      groups by specified characteristics, in this case whether or not they had conceived by IVF or
      not (or sub-categorised by individual factors within the IVF treatment process, such as
      whether the embryo was transferred fresh or after a period of cryopreservation). No active
      intervention (medicine or procedure) will be administered during the study. However, it is
      known that health outcomes of individuals participating in research may be influenced by the
      experience of participating in the study itself. For this reason the investigators will also
      recruit "control" participants (those who have conceived without IVF, either spontaneously or
      with medication to aid the release of eggs, known as ovulation induction). By comparing the
      two groups, this will enable the research to isolate the specific effects of the
      IVF-conception, from the effects of being highly monitored in a research study. The
      investigators intend to recruit a minimum of 120 individuals across a period of three years,
      with approximately 4 individuals who have conceived by IVF to every 1 individual who has
      conceived without IVF.

      Appointments in the START clinic will be arranged roughly 4-6 weekly (at approximately 9, 17,
      23, 28, 33, 37 and 41 weeks). At each appointment the patient will be reviewed by a doctor
      and midwife from a small team of clinicians who will provide continuity of care. Routine
      scheduled antenatal care will be performed, along with additional measurements of fetal and
      placental growth and cardiovascular function, questionnaires relating to environmental
      exposures, modifiable risks, and emotional health, and samples of maternal blood, urine,
      saliva and hair. More frequent appointments will be scheduled according to local hospital
      guidance if complications of pregnancy are suspected or confirmed, this may mean that
      clinical measurements and ultrasound examinations are performed more frequently than at the
      planned study visits. Questionnaires and biological samples will only be
      administered/obtained at the (study visit closest to) stated gestational intervals.
      Participants will be made aware of which measurements are part of standard antenatal care and
      which investigations are for research; research measurements will be analysed blinded to
      participant identity/pregnancy outcome after conclusion of the pregnancy and will not
      contribute to their care during or after the pregnancy. Participants can decline particular
      investigations entirely or on occasion without detriment to their overall care. Where
      necessary, according to the individual needs of the participant, antenatal care will be
      shared with community midwives and other antenatal services where additional appointments are
      required outside the stated schedule.

      At birth, the placenta and fetal blood contained within it after clamping of the umbilical
      cord, will be collected. Placental tissue may be used immediately after birth in experiments
      to study how it functions, or small amounts may be processed and stored (according to local
      standard operating procedures) for later assessment of its structure and functional
      footprint. Should histopathological examination of the placenta be indicated for clinical
      reasons (<5% of all pregnancies), the remaining placental tissue will be made available for
      this purpose according to standard local protocols for combined research and
      histopathological placental examination; otherwise unused placental tissue will be disposed
      sensitively according to local National Health Service procedures. Prior to discharge from
      the hospital, and preferably within 3 days of birth, the baby will be measured (using a tape
      measure) once for head, abdominal and thigh circumference, and length. Their skinfold
      thickness (to measure fat depth) over the shoulder blade and under the upper arm will be
      measured using purpose-built callipers. The baby will be kept warm and comfortable
      throughout, and the examination paused or stopped should the baby show distress, need feeding
      or changing or any medical intervention be required.
observational model: Cohort
time perspective: Prospective
measure: Recruitment feasibility: Number of referrals received
time frame: 3 years
measure: Recruitment feasibility: Proportion of referrals eligible for recruitment
time frame: 3 years
measure: Recruitment feasibility: Proportion of eligible individuals accepting recruitment
time frame: 3 years
measure: Recruitment feasibility: Rate of recruitment
time frame: 3 years
measure: Recruitment feasibility: Gestation at referral/first appointment
time frame: 3 years
measure: Recruitment feasibility: Rate of consent to contact for future studies involving mother or child
time frame: 3 years
measure: Protocol feasibility: Proportion of recruits completing all study visits
time frame: 3 years
measure: Protocol feasibility: Average number of study visits required by each individual
time frame: 3 years
measure: Protocol feasibility: Proportion of individuals accepting each type/gestation of investigation
time frame: 3 years
measure: Protocol feasibility: Reliability of each type/gestation of investigation
time frame: 3 years
measure: Protocol feasibility: Rate of withdrawal / loss to follow up
time frame: 3 years
measure: Protocol feasibility: Proportion of recruits where fertility records could be accessed
time frame: 3 years
measure: Missing data: Proportion of recruits scanned before 12 weeks' gestation
time frame: 3 years
measure: Missing data: Proportion of missing data points for each type/gestation of investigation
time frame: 3 years
measure: Missing data: Proportion of fertility treatment variables that could be ascertained from fertility records
time frame: 3 years
arm group label: IVF-conceived
description: Those who have conceived by IVF (for whatever indication); target 80 participants of which it is anticipated 20 would have conceived by frozen embryo transfer IVF.
arm group label: Spontaneously conceived
description: Those who have conceived spontaneously (within 12 months and without use of hormonal or other contraception); target 20 participants
arm group label: Ovulation induction-conceived
description: Those who have conceived by ovulation induction (after more than 12 months); target 20 participants.
intervention type: Other
intervention name: Non-interventional cohort study
description: Non-interventional cohort study
arm group label: IVF-conceived
arm group label: Ovulation induction-conceived
arm group label: Spontaneously conceived
Maternal blood (pre-delivery) Maternal urine Maternal saliva Maternal hair Placental tissue
      Umbilical cord blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lucy Higgins, PhD MRCOG
phone: +441617016957
email: lucy.higgins@manchester.ac.uk
last name: Ed Johnstone, PhD MRCOG
email: edward.johnstone@manchester.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Manchester Academic Health Science Centre
investigator full name: Lucy Higgins
investigator title: NIHR Academic Clinical Lecturer in Obstetrics
mesh term: Pre-Eclampsia
mesh term: Pregnancy Complications
mesh term: Fetal Growth Retardation
mesh term: Placenta Diseases
sharing ipd: Yes
ipd description: After publication of the study findings and complete anonymisation of the data, individual patient data will be deposited in an online data repository such as Mendeley Data
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: 3 to 5 years
ipd access criteria: Open access for completely anonymised data with appropriate metadata for interpretation. Applications to access pseudonymised data may be considered in writing to the principal investigator, subject to appropriate local approvals and a data management plan that conforms to the requirements of the University of Manchester.