Premature Rupture of Membranes at TermPhase 4NCT00355303
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in 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
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2006to May 2013
- 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.
India1 site
Nilratan Sircar Medical College, 138,AJC Bose Road,
Kolkata, West Bengal, 700014
About this study
Official title: Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.
- Conditions
- Premature Rupture of Membranes at Term
- Being tested
- Misoprostol, PGE2 gel
- Keywords
- Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Misoprost
Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses
PGE2 gelDrug
Also called Dinoprostone gel
PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol tablet, PGE2 gel | Active comparator | participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval. Receives: Drug: Misoprostol; Drug: PGE2 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean Section rate
Measured: 48 hours
Secondary outcomes (2)
Induction delivery time
Measured: 48 hours
Neonatal & maternal infectious morbidity
Measured: 14 days following date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2013
- Study completionMay 2013
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilratan Sircar Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Snehamay Chaudhuri, Nilratan Sircar Medical College
- Investigators
- Snehamay Chaudhuri, MBBS,MD.DNB, Principal investigator, Nilratan Sircar Medical College , Kolkata, West bengal , India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355303
- Sponsor's protocol ID
- 2-Chaudhuri
- Status last verified
- Jul 2015
- First submitted
- 19 Jul 2006
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT00355303
- Acronym / sponsor ID
- 2-Chaudhuri
- Conditions
- Premature Rupture of Membranes at Term
- Keywords
- Premature rupture of membranes at term, Induction of labour, Misoprostol, PGE2 gel, Immediate induction with PGE2 gel, Immediate induction with Misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 932 participants (actual)
- Lead sponsor
- Nilratan Sircar Medical CollegeOther government
- Study start
- Aug 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 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.
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misoprostol tablet, PGE2 gel | Active comparator | Drug: Misoprostol, Drug: PGE2 gelparticipants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval. |
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 |
|---|---|---|
| MisoprostolAlso: MisoprostVaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses | Drug | Misoprostol tablet, PGE2 gel |
| PGE2 gelAlso: Dinoprostone gelPGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses | Drug | Misoprostol tablet, PGE2 gel |
Primary outcome
Caesarean Section rate
Time frame: 48 hours
2 secondary outcomes
Induction delivery time
Time frame: 48 hours
Neonatal & maternal infectious morbidity
Time frame: 14 days following date of delivery
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 22 Jul 2015.
Related trials for Premature Rupture of Membranes at Term
Recruiting
Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Meconium-stained Amniotic Fluid, Chorioamnionitis
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
Nilratan Sircar Medical College , Kolkata, West bengal , 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 22 Jul 2015. 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?
Caesarean Section rate (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 22 Jul 2015.