ClinicalTrials.gg
CompletedNCT00355966Updated Mar 25, 2010

Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

A Phase 4 interventional study of Misoprostol and PGE2 gel in Premature Rupture of Membranes at Term, sponsored by Nilratan Sircar Medical College. Completed at 1 site in India. Open to female participants. Per ClinicalTrials.gov, last updated 2010-03-25.

Sponsored by Nilratan Sircar Medical College · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
212
Allocation
Randomized
Sex
Female
01

Study summary

Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.

02

Conditions studied

  • Premature Rupture of Membranes at Term

Keywords

  • Premature rupture of membranes
  • Induction of labour with Misoprostol
  • Induction of labour with PGE2 gel
03

In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's enrollment of 212 is above the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

Nilratan Sircar Medical College is the lead sponsor of 8 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Premature rupture of membranes at 37 or more weeks
  • Single live fetus in cephalic presentation

Exclusion criteria

Exclusion Criteria:

  • Women in labour
  • Women with of induction of labour
  • Women with previous caesarean section or uterine surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Active comparator
    A

    In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

    Drug: Misoprostol

  • Active comparator
    B

    In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.

    Drug: PGE2 gel

Interventions

  • In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

  • In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.

06

What researchers measure

Primary outcomes

  1. Admission to delivery time

    Time frame: 48 hours

Secondary outcomes

  1. Caesarean Section rate

    Time frame: 48 hours

  2. Neonatal morbidity

    Time frame: Till discharge

  3. Maternal morbidity

    Time frame: Till discharge

07

Study locations

1 site
  • NRS Medicl College,138 AJC Bose Road
    Kolkata, West Bengal 700014, India
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006, a primary completion of Sep 2008 and a completion of Sep 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2006
First posted
Jul 25, 2006
Start
Aug 2006
Primary completionActual
Sep 2008
CompletionActual
Sep 2008
Last update
Mar 25, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00355966
Lead sponsor
Nilratan Sircar Medical College
First posted
Jul 25, 2006
Start date
Aug 2006
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Mar 25, 2010

Study contacts

Snehamay Chaudhuri, MBBS,MD,DNB
principal investigator · NRS Medical College , Kolkata, India

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Misoprostol · Dinoprostone

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