Early Versus Late Amniotomy Following EAB Cervical Ripening

August 30, 2023 updated by: Eran Brazilay, MD PhD, Assuta Ashdod Hospital

Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

Induction of labor is a common obstetric procedure with a reported rate of 23.3% in 2012 in the United State. It has been recently reported that Induction of labor at full term in uncomplicated singleton gestations is not associated with increased risk of cesarean delivery and overall has similar outcomes compared to expectant management.

Induction of labor in women with an unripened cervix is comprised of two stages, cervical ripening followed by augmentation of labor.

Extra amniotic balloon inflation is a widespread mechanical method of cervical ripening that commonly results in a ripened cervix open to 3-4 cm without significant uterine contractions. At this point the clinician may opt to perform artificial rupture of membranes or rather first begin oxytocin infusion delaying amniotomy to later stages of labor. A retrospective cohort showed early amniotomy after Foley balloon catheter removal was associated with shorter duration of labor induction among nulliparous women.In accordance, an RCT investigating the efficacy of early amniotomy in nulliparous women showed this practice resulted in labor shortening without increasing the rate of cesarean section, yet these women were treated by different methods for cervical ripening. Contradicting results were shown in a randomized controlled trial addressing the very question of early versus late amoniotomy after balloon ripening, concluding that postponing amniotomy until active labor commences results in a reduction of dystocia indicated cesarean section. However no distinction was made in this study between nulliparous and multiparous parturients. Since these comprise different groups with distinct labor curves, the question remains whether one should consider parity when deciding to perform early vs late amniotomy following balloon expulsion.

Both Amniotomy and Oxytocine infusion are part of the routine protocol and necessary procedures for induction of labor. Adverse outcome of amniotomy includes fetal heart rate changes, cord prolapse and intrapartum fever when labor is prolonged. Adverse outcome of oxytocine include hypertonus and fetal heart rate changes requiring cessation of oxytocine infusion (as in routine protocol) and intrapartum fever if labor is prolonged (not due to oxytocine infusion per se). Most of the patients admitted for induction of labor will need both amniotomy and oxytocine, however the role of the order of these two procedures is unclear ,as well as whether the order of these procedures affect the rate of adverse outcome.

The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.

STUDY PROTOCOL Multicenter randomized control trial that will be conducted in 4 medical centers in Israel.

Women with a singleton viable gestation undergoing indicated labor induction at term (37-42 weeks of gestation) who undergoing induction of labor at term with a low bishop score<4 who require extra amniotic balloon cervical ripening will be asked to participate in the study. Written informed consent will be obtained from all patients.

Early amniotomy- Amniotomy performed as the exclusive primary intervention to augment labor following expulsion of the EAB regardless of cervical dilatation.

Late amniotomy- EAB expulsion is followed by oxytocin infusion at increasing increments as the primary intervention as an exclusive intervention for at least 2 hours.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ashdod, Israel
        • Assuta Ashdod

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Gestational age 37-42 weeks
  2. Singleton pregnancy
  3. Vertex presentation
  4. Medical indication for induction of labor
  5. Need for cervical ripening (Bishop score <=6)
  6. Consent to participate in the study
  7. Women age at or >18 years

Exclusion Criteria:

  1. Multiple pregnancies
  2. Preterm pregnancy
  3. Previous cesarean section
  4. Uterine malformation
  5. Withdrawal of consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early amniotomy group
Amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy.
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Names:
  • Oxytocin
Other: Late amniotomy group
Oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Names:
  • Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to delivery
Time Frame: Up to 96 Hours
The time from induction defined as the primary intervention following balloon expulsion to delivery.
Up to 96 Hours
Delivery within 24 hours
Time Frame: Up to 96 Hours
The proportion of women that delivered within 24 hours of induction
Up to 96 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean delivery
Time Frame: Up to 96 Hours
Cesarean delivery rates and indications
Up to 96 Hours
Operative delivery
Time Frame: Up to 96 Hours
Operative delivery rates and indications
Up to 96 Hours
Intrapartum fever
Time Frame: Up to 96 Hours
Fever >38 degrees Celsius during labor
Up to 96 Hours
Postpartum fever during the postpartum hospital stay
Time Frame: Up to 7 days
Fever >38 degrees Celsius > 24hours after delivery
Up to 7 days
Post partum hemorrhage
Time Frame: Up to 7 days
Estimation of obstetrician >500cc bleeding post partum for vaginal delivery or>1000 cc at cesarean section
Up to 7 days
Neonatal outcomes- Apgar
Time Frame: 10 minutes
Apgar score
10 minutes
Neonatal outcomes - PH umbilical
Time Frame: 10 minutes
PH of vein and or artery of umbilical cord
10 minutes
Neonatal outcomes- NICU admission
Time Frame: Up to 30 days
Admission to Neonatal Intensive Care Unit
Up to 30 days
Neonatal outcomes- infection
Time Frame: Up to 30 days
Neonatal fever/sepsis
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yael Ganor Paz, MD, Assuta Ashdod Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Actual)

January 11, 2023

Study Completion (Actual)

January 11, 2023

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

January 1, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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