NCT02856724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

August 2, 2016

Last Update Submit

December 6, 2016

Conditions

Early Amniotomy, Unfavorable Cervix

Outcome Measures

Primary Outcomes (1)

  • induction-to- delivery time

    delivery (the length of time between the beginning of induction and the end of labor)

Secondary Outcomes (2)

  • mode of labor (vaginal or C-section)

    delivery

  • successful induction

    vaginal delivery within 24 h from the beginning of induction

Study Arms (2)

Early amniotomy and PGE2

EXPERIMENTAL

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

PGE2

ACTIVE COMPARATOR

10 mg PGE2 vaginal ovul(Propess)

Drug: PGE2

Interventions

PGE2DRUG

10 mg PGE2 vaginal ovul(Propess)

Also known as: dinoprostone
Early amniotomy and PGE2PGE2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients who have contraindications for vaginal delivery,
  • previous uterine surgery,
  • fetal malpresentation,
  • multifetal pregnancy,
  • more than three contractions in 10 minutes,
  • contraindications to prostaglandins,
  • a category II or III fetal heart rate pattern,
  • anomalous fetus,
  • fetal demise
  • women with immediate delivery indications -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Woman and Child Diseases Education and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • Ozkan S, Caliskan E, Doger E, Yucesoy I, Ozeren S, Vural B. Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. Arch Gynecol Obstet. 2009 Jul;280(1):19-24. doi: 10.1007/s00404-008-0843-9. Epub 2008 Nov 26.

    PMID: 19034471BACKGROUND

  • 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;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.

    PMID: 23926074BACKGROUND

  • Makarem MH, Zahran KM, Abdellah MS, Karen MA. Early amniotomy after vaginal misoprostol for induction of labor: a randomized clinical trial. Arch Gynecol Obstet. 2013 Aug;288(2):261-5. doi: 10.1007/s00404-013-2747-6. Epub 2013 Feb 21.

    PMID: 23430026RESULT

Related Links

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • evrim bostanci ergen, M.D.

    Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 5, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

TU(1)