<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/NCT03039036</url>
  </required_header>
  <id_info>
    <org_study_id>STU00204292</org_study_id>
    <nct_id>NCT03039036</nct_id>
  </id_info>
  <brief_title>Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction</brief_title>
  <official_title>A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However,&#xD;
      the timing is highly variable. The purpose of this study is to determine if first time&#xD;
      mothers undergoing induction of labor with a Foley catheter experience a decrease in their&#xD;
      labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley&#xD;
      catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least&#xD;
      4 hours after Foley catheter removal). Other aims include the relationship between timing of&#xD;
      amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar&#xD;
      score &lt;7 at 5 minutes, neonatal need for intensive care.&#xD;
&#xD;
      The investigators hypothesize that induction of labor with Foley catheters followed by early&#xD;
      amniotomy will result in a decreased duration of labor compared to those who undergo delayed&#xD;
      amniotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized clinical trial of consenting nulliparous women undergoing induction of labor&#xD;
      with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy&#xD;
      within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with&#xD;
      delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).&#xD;
&#xD;
      This project will include 110 women recruited from the obstetrical service at Prentice&#xD;
      Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a&#xD;
      singleton pregnancy, have intact membranes and are undergoing an induction of labor using a&#xD;
      Foley catheter. Following removal of Foley catheter, women will be assessed for safety of&#xD;
      amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.&#xD;
&#xD;
      Women will be randomized with equal probability to the intervention group using block&#xD;
      randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.&#xD;
&#xD;
      Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter&#xD;
      removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours&#xD;
      following Foley removal. The remainder of labor management will be at the discretion of each&#xD;
      woman's obstetric provider.&#xD;
&#xD;
      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained&#xD;
      via chart review&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time interval from Foley catheter removal to delivery</measure>
    <time_frame>Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.</time_frame>
    <description>Hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cesarean delivery</measure>
    <time_frame>At time of delivery</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chorioamnionitis</measure>
    <time_frame>From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours</time_frame>
    <description>Maternal Temperature of &gt;/= 39 degrees Celsius or &gt;/= 38 degrees Celsius on two occasions greater than 30 minutes apart and at least one of the following: Fetal tachycardia (defined as sustained (&gt;10 min) fetal heart rate &gt;160), White Bood Cell Count &gt;15, purulent fluid from cervical os, or receipt of antibiotics and diagnosis written in the chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum Fever</measure>
    <time_frame>From time of delivery to time of hospital discharge; up to 6 weeks</time_frame>
    <description>Temperature &gt;/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound infection</measure>
    <time_frame>From time of delivery to time of hospital discharge; up to 6 weeks</time_frame>
    <description>Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometritis</measure>
    <time_frame>From time of delivery to time of hospital discharge; up to 6 weeks</time_frame>
    <description>fundal tenderness and fever that required treatment with antibiotics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 minute Apgar Score less than 7 out of 10</measure>
    <time_frame>5 minutes following delivery; 5 minutes of neonatal life.</time_frame>
    <description>Neonatal Apgar scores consist of measurements of neonatal skin color, respiratory rate, heart rate, muscle tone, and irritability. Each parameter is given a score of 0, 1 or 2 based on standardized parameters. It is standard to perform this on all neonates at 1 minute and 5 minutes of life. Apgar scores are performed and calculated by nursing staff or members of the pediatric team. For this outcome, we are interested in scores less than 7 out of 10 at 5 minutes of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal intensive care unit admission</measure>
    <time_frame>From time of delivery to hospital discharge; up to 6 weeks</time_frame>
    <description>Admission to the neonatal intensive care unit for greater than 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Labor</measure>
    <time_frame>Time from placement of Foley catheter to time of delivery of neonate; up to 5 days</time_frame>
    <description>hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected or confirmed neonatal sepsis</measure>
    <time_frame>From time of delivery to hospital discharge; up to 6 weeks</time_frame>
    <description>As clinical suspected by the neonatology team or with positive cultures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum hemorrhage</measure>
    <time_frame>From time of delivery to time of hospital discharge; up to 6 weeks</time_frame>
    <description>Delivery estimated blood loss of &gt; 500 cc for vaginal delivery or &gt; 1000 cc for cesarean delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery time less than 24 hours</measure>
    <time_frame>From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.</time_frame>
    <description>binary; yes/no</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Labor Induction</condition>
  <arm_group>
    <arm_group_label>Early Amniotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Amniotomy</intervention_name>
    <description>Artificially rupturing membranes</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley Catheter</intervention_name>
    <description>Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.</description>
    <arm_group_label>Delayed Amniotomy</arm_group_label>
    <arm_group_label>Early Amniotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Women age 18 years old or greater&#xD;
&#xD;
          -  Nulliparous&#xD;
&#xD;
          -  Pregnant with a singleton gestation that is greater than or equal to 37 weeks&#xD;
&#xD;
          -  Undergoing induction of labor with Foley catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women not meeting above criteria&#xD;
&#xD;
          -  Fetus in non-cephalic position&#xD;
&#xD;
          -  Intrauterine fetal demise&#xD;
&#xD;
          -  Fetus with major anomalies&#xD;
&#xD;
          -  HIV, hepatitis B or C infection&#xD;
&#xD;
          -  Planned use of oxytocin during the Foley catheter ripening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.</citation>
    <PMID>24941926</PMID>
  </reference>
  <reference>
    <citation>Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8.</citation>
    <PMID>10831992</PMID>
  </reference>
  <reference>
    <citation>Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18.</citation>
    <PMID>26868065</PMID>
  </reference>
  <reference>
    <citation>Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.</citation>
    <PMID>23303106</PMID>
  </reference>
  <reference>
    <citation>Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.</citation>
    <PMID>23780653</PMID>
  </reference>
  <reference>
    <citation>Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.</citation>
    <PMID>16885669</PMID>
  </reference>
  <reference>
    <citation>Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.</citation>
    <PMID>22419277</PMID>
  </reference>
  <reference>
    <citation>Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2.</citation>
    <PMID>26837386</PMID>
  </reference>
  <reference>
    <citation>Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.</citation>
    <PMID>11888099</PMID>
  </reference>
  <reference>
    <citation>Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.</citation>
    <PMID>27500341</PMID>
  </reference>
  <reference>
    <citation>Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.</citation>
    <PMID>27824758</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Emily Miller</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Labor Induction</keyword>
  <keyword>Early Amniotomy</keyword>
  <keyword>Foley catheter</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03039036
org study id: STU00204292
nct id: NCT03039036
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However,
      the timing is highly variable. The purpose of this study is to determine if first time
      mothers undergoing induction of labor with a Foley catheter experience a decrease in their
      labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley
      catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least
      4 hours after Foley catheter removal). Other aims include the relationship between timing of
      amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar
      score <7 at 5 minutes, neonatal need for intensive care.

      The investigators hypothesize that induction of labor with Foley catheters followed by early
      amniotomy will result in a decreased duration of labor compared to those who undergo delayed
      amniotomy.
This randomized clinical trial of consenting nulliparous women undergoing induction of labor
      with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy
      within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with
      delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).

      This project will include 110 women recruited from the obstetrical service at Prentice
      Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a
      singleton pregnancy, have intact membranes and are undergoing an induction of labor using a
      Foley catheter. Following removal of Foley catheter, women will be assessed for safety of
      amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.

      Women will be randomized with equal probability to the intervention group using block
      randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.

      Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter
      removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours
      following Foley removal. The remainder of labor management will be at the discretion of each
      woman's obstetric provider.

      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
      via chart review
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time interval from Foley catheter removal to delivery
time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
description: Hours
measure: Cesarean delivery
time frame: At time of delivery
description: binary; yes/no
measure: Chorioamnionitis
time frame: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
description: Maternal Temperature of >/= 39 degrees Celsius or >/= 38 degrees Celsius on two occasions greater than 30 minutes apart and at least one of the following: Fetal tachycardia (defined as sustained (>10 min) fetal heart rate >160), White Bood Cell Count >15, purulent fluid from cervical os, or receipt of antibiotics and diagnosis written in the chart
measure: Postpartum Fever
time frame: From time of delivery to time of hospital discharge; up to 6 weeks
description: Temperature >/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart
measure: Wound infection
time frame: From time of delivery to time of hospital discharge; up to 6 weeks
description: Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever
measure: Endometritis
time frame: From time of delivery to time of hospital discharge; up to 6 weeks
description: fundal tenderness and fever that required treatment with antibiotics
measure: 5 minute Apgar Score less than 7 out of 10
time frame: 5 minutes following delivery; 5 minutes of neonatal life.
description: Neonatal Apgar scores consist of measurements of neonatal skin color, respiratory rate, heart rate, muscle tone, and irritability. Each parameter is given a score of 0, 1 or 2 based on standardized parameters. It is standard to perform this on all neonates at 1 minute and 5 minutes of life. Apgar scores are performed and calculated by nursing staff or members of the pediatric team. For this outcome, we are interested in scores less than 7 out of 10 at 5 minutes of life.
measure: Neonatal intensive care unit admission
time frame: From time of delivery to hospital discharge; up to 6 weeks
description: Admission to the neonatal intensive care unit for greater than 24 hours
measure: Length of Labor
time frame: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
description: hours
measure: Suspected or confirmed neonatal sepsis
time frame: From time of delivery to hospital discharge; up to 6 weeks
description: As clinical suspected by the neonatology team or with positive cultures
measure: Postpartum hemorrhage
time frame: From time of delivery to time of hospital discharge; up to 6 weeks
description: Delivery estimated blood loss of > 500 cc for vaginal delivery or > 1000 cc for cesarean delivery
measure: Delivery time less than 24 hours
time frame: From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.
description: binary; yes/no
arm group label: Early Amniotomy
arm group type: Experimental
description: Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal.
arm group label: Delayed Amniotomy
arm group type: Active Comparator
description: Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter.
intervention type: Procedure
intervention name: Amniotomy
description: Artificially rupturing membranes
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
intervention type: Device
intervention name: Foley Catheter
description: Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
intervention type: Drug
intervention name: Misoprostol
description: Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.
arm group label: Delayed Amniotomy
arm group label: Early Amniotomy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emily Miller, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
PMID: 24941926
citation: Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8.
PMID: 10831992
citation: Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18.
PMID: 26868065
citation: Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
PMID: 23303106
citation: Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.
PMID: 23780653
citation: Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.
PMID: 16885669
citation: Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
PMID: 22419277
citation: Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2.
PMID: 26837386
citation: Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
PMID: 11888099
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responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Emily Miller
investigator title: Assistant Professor of Obstetrics and Gynecology
mesh term: Misoprostol
sharing ipd: No