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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04496908
Other study ID # DDD# 604698
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 16, 2020
Est. completion date October 18, 2021

Study information

Verified date November 2021
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. 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 combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date October 18, 2021
Est. primary completion date May 22, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - =18 years of age - full term (=37 weeks) gestations determined by routine obstetrical guidelines - singleton gestation in cephalic presentation - Both nulliparous and multiparous women - Intact membranes - Bishop score of =6 and cervical dilation =2cm Exclusion Criteria: - Any contraindication to a vaginal delivery or to misoprostol - fetal demise - Multifetal gestation - major fetal anomaly - prior uterine surgery, previous cesarean section - women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage - Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.

Study Design


Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn
  • Rupture

Intervention

Procedure:
amniotomy
Artificially rupturing membranes
Device:
Foley Catheter
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.
Drug:
Misoprostol
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.

Locations

Country Name City State
United States Christiana Care Health Systems Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (5)

Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0. — View 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. — View 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. — View Citation

Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24. — View Citation

Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary time to delivery time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery. Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary Cesarean delivery rate binary; yes/no At time of delivery
Secondary Time to vaginal delivery time to delivery (hours) defined as time from Foley Catheter expulsion to delivery At time of delivery
Secondary Maternal length of stay time from admission to discharge through study completion, an average of 4 days
Secondary Indication for cesarean delivery discrete At time of delivery
Secondary Chorioamnionitis defined by the presence of maternal fever =100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness At time of delivery
Secondary 3rd/4th degree perineal laceration binary; yes/no at time of delivery
Secondary Blood transfusion binary; yes/no through study completion, an average of 1 year
Secondary Endometritis binary; yes/no From time of delivery to time of hospital discharge; up to 6 weeks
Secondary Wound separation-infection binary, yes/no; defined by the need for additional wound closure or the need for antibiotics through study completion, an average of 1 year
Secondary Neonatal death binary, yes/no through study completion, an average of 1 year
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