CClinicalTrials.gg
Sign In
CompletedNCT02856724PGE2Updated Dec 8, 2016

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

A Phase 2 interventional study of PGE2 in Early Amniotomy, Unfavorable Cervix, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Early Amniotomy, Unfavorable Cervix
03

In context

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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 -
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • 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

  • Active comparator
    PGE2

    10 mg PGE2 vaginal ovul(Propess)

    Drug: PGE2

Interventions

  • DrugPGE2

    10 mg PGE2 vaginal ovul(Propess)

    Also known as: dinoprostone

06

What researchers measure

Primary outcomes

  1. induction-to- delivery time

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

Secondary outcomes

  1. mode of labor (vaginal or C-section)

    Time frame: delivery

  2. successful induction

    Time frame: vaginal delivery within 24 h from the beginning of induction

07

Study locations

1 site
  • Zeynep Kamil Woman and Child Diseases Education and Research Hospital
    Istanbul, 34000, Turkey
08

References and documents

Publications

  • 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. PubMed 19034471 ↗
  • 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. PubMed 23926074 ↗
  • 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. PubMed 23430026 ↗

Related links

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02856724
Lead sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible party
Ahmet Eser (medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital) — Principal investigator
First posted
Aug 5, 2016
Start date
Aug 2016
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Dec 8, 2016

Study contacts

evrim bostanci ergen, M.D.
study director · Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Start the discussion