Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial (PGE2)

December 6, 2016 updated by: Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Zeynep Kamil Woman and Child Diseases Education and Research Hospital

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria

  1. singleton pregnancy,
  2. gestational age ≥34 weeks,
  3. intact membranes,
  4. cephalic presentation,
  5. bishop score ≤5,
  6. had obstetrical indications for induction of labor,
  7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

  1. Patients who have contraindications for vaginal delivery,
  2. previous uterine surgery,
  3. fetal malpresentation,
  4. multifetal pregnancy,
  5. more than three contractions in 10 minutes,
  6. contraindications to prostaglandins,
  7. a category II or III fetal heart rate pattern,
  8. anomalous fetus,
  9. fetal demise
  10. women with immediate delivery indications -

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early amniotomy and PGE2
10 mg PGE2 vaginal ovul(Propess) Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.
Drug: PGE2
10 mg PGE2 vaginal ovul(Propess)
Other Names:
  • dinoprostone
ACTIVE_COMPARATOR: PGE2
10 mg PGE2 vaginal ovul(Propess)
Drug: PGE2
10 mg PGE2 vaginal ovul(Propess)
Other Names:
  • dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
induction-to- delivery time
Time Frame: delivery (the length of time between the beginning of induction and the end of labor)
delivery (the length of time between the beginning of induction and the end of labor)

Secondary Outcome Measures

Outcome Measure
Time Frame
mode of labor (vaginal or C-section)
Time Frame: delivery
delivery
successful induction
Time Frame: vaginal delivery within 24 h from the beginning of induction
vaginal delivery within 24 h from the beginning of induction

Collaborators and Investigators

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

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Study Director: evrim bostanci ergen, M.D., Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

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

Helpful Links

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

August 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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