Premature Rupture of Membranes at TermPhase 4NCT00355966
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
A Phase 4 study testing Misoprostol and PGE2 gel in people with Premature Rupture of Membranes at Term, run by Nilratan Sircar Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Rupture of Membranes at Term
- What is being tested?
- Misoprostol and PGE2 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Premature rupture of membranes at 37 or more weeks
- Single live fetus in cephalic presentation
Who cannot join
- Women in labour
- Women with contraindication of induction of labour
- Women with previous caesarean section or uterine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term
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.
- Conditions
- Premature Rupture of Membranes at Term
- Being tested
- Misoprostol, PGE2 gel
- Keywords
- Premature rupture of membranes, Induction of labour with Misoprostol, Induction of labour with PGE2 gel
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .
PGE2 gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses . Receives: Drug: Misoprostol |
| B | Active comparator | 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. Receives: Drug: PGE2 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to delivery time
Measured: 48 hours
Secondary outcomes (3)
Caesarean Section rate
Measured: 48 hours
Neonatal morbidity
Measured: Till discharge
Maternal morbidity
Measured: Till discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of Membranes at TermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilratan Sircar Medical College
- Sponsor type
- Other government
- Investigators
- Snehamay Chaudhuri, MBBS,MD,DNB, Principal investigator, NRS Medical College , Kolkata, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355966
- Sponsor's protocol ID
- 1-Chaudhuri
- Status last verified
- Nov 2008
- First submitted
- 18 Jul 2006
- Last updated
- 25 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term
- ClinicalTrials.gov ID
- NCT00355966
- Acronym / sponsor ID
- 1-Chaudhuri
- Conditions
- Premature Rupture of Membranes at Term
- Keywords
- Premature rupture of membranes, Induction of labour with Misoprostol, Induction of labour with PGE2 gel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Nilratan Sircar Medical CollegeOther government
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: MisoprostolIn group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses . |
| B | Active comparator | Drug: PGE2 gelIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Premature rupture of membranes at 37 or more weeks
- Single live fetus in cephalic presentation
Key exclusion criteria (3 listed)
- Women in labour
- Women with contraindication of induction of labour
- Women with previous caesarean section or uterine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolIn one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses . | Drug | A |
| PGE2 gelIn 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. | Drug | B |
Primary outcome
Admission to delivery time
Time frame: 48 hours
3 secondary outcomes
Caesarean Section rate
Time frame: 48 hours
Neonatal morbidity
Time frame: Till discharge
Maternal morbidity
Time frame: Till discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2010.
- Chaudhuri S, Mitra SN, Biswas PK, Bhattcharyya S.Pramature rupture of membranes at term: Immediate induction with PGE2 gel compared with delayed induction with oxytocin,Ind J Obstet Gynecol Vol56,no 3; 2006,224-229Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snehamay Chaudhuri, MBBS,MD,DNB principal investigator
NRS Medical College , Kolkata, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and PGE2 gel in people with Premature Rupture of Membranes at Term, run by Nilratan Sircar Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to delivery time (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2010.