Prelabor Rupture of MembranesPROMNCT07261332
Early V/S Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes
A study testing 0.5mg PGE2 gel in people with Prelabor Rupture of Membranes and Labor (Obstetrics)--Complications, run by Laiba Qamar at 1 site in Pakistan.
Trial summary
To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prelabor Rupture of Membranes, Labor (Obstetrics)--Complications, Induction of Labor
- What is being tested?
- 0.5mg PGE2 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2025to 10 Oct 2025
- Phase
- Interventional
- 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
- singleton pregnancy with cephalic presentation
- gestational age between 37-41 weeks as calculated by last menstrual period date or early dating ultrasoumd
- Spontaeous PROM as confirmed by history and sterile speculum examination
- modified bishop score <6
- no detectable uterine contractions on admission
- clear liqour and duration of PROM <6 hours at admission
Who cannot join
- meconium stained liqour
- patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge
- maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease
- presence of contraindications to labour such as placenta previa , Vasa previa,previous uterine surgery (e.g myomectomy ) that increases the risk of uterine rupture , previous C section
- history of antepartum hemorrhage
- Moderate to severe IUGR as diagnosed on ultrasound and doppler studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on Early Versus Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes at Term
To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour.
Read the detailed description
This is a comparative study where the patient who presented with PROM were assigned 2 groups of intervention . One had early induction of labour and other had induction of labour after 24 hours of observation. Both groups were compared for the average time of labour till delivery of the fetus and the frequency of spontaneous vaginal delivery was also calculated for each group.
- Being tested
- 0.5mg PGE2 gel
- Keywords
- prelabor rupture of membranes, complicated labor, early Versus delayed labor induction
- 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.
0.5mg PGE2 gelDrug
In this interventional group patients presenting with PROM will be immediately induced by 0.5mg PGE2 gel. If bishop score will not improve after 6 hours, then application of PGE2 gel will be repeated (maximum 2 doses)
0.5mg PGE2 gelDrug
The patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina.
| Study group | Role | What they receive |
|---|---|---|
| early induction of labour for PROM | Experimental | The patients assigned with this arm when presented with PROM were inducted immidiately for labour and no observation was done for 24 hours for spontaneous induction of labour Receives: Drug: 0.5mg PGE2 gel |
| Late induction of Labour in PROM | Active comparator | The patients assigned with this arm were observed for 24 hours for any spontanous induction of labour and then only proceeded with manual induction. Receives: Drug: 0.5mg PGE2 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labour
the duration of labour was assesed after each method of induction when patients presented with PROM
Measured: 24 hours
Secondary outcomes (1)
Frequency of Normal Vaginal Delivery
Frequency of having a vaginal delivery was calculated in each interventional group
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start10 May 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prelabor Rupture of MembranesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laiba Qamar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laiba Qamar, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261332
- Sponsor's protocol ID
- #PLROM225#
- Acronym
- PROM
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants have not given the cosent to share their personal data
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Early Versus Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes at Term
- ClinicalTrials.gov ID
- NCT07261332
- Acronym / sponsor ID
- PROM / #PLROM225#
- Keywords
- prelabor rupture of membranes, complicated labor, early Versus delayed labor induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Laiba QamarUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- 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.
To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour.
Detailed description
This is a comparative study where the patient who presented with PROM were assigned 2 groups of intervention . One had early induction of labour and other had induction of labour after 24 hours of observation. Both groups were compared for the average time of labour till delivery of the fetus and the frequency of spontaneous vaginal delivery was also calculated for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early induction of labour for PROM | Experimental | Drug: 0.5mg PGE2 gelThe patients assigned with this arm when presented with PROM were inducted immidiately for labour and no observation was done for 24 hours for spontaneous induction of labour |
| Late induction of Labour in PROM | Active comparator | Drug: 0.5mg PGE2 gelThe patients assigned with this arm were observed for 24 hours for any spontanous induction of labour and then only proceeded with manual induction. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- singleton pregnancy with cephalic presentation
- gestational age between 37-41 weeks as calculated by last menstrual period date or early dating ultrasoumd
- Spontaeous PROM as confirmed by history and sterile speculum examination
- modified bishop score <6
- no detectable uterine contractions on admission
Key exclusion criteria (6 listed)
- meconium stained liqour
- patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge
- maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease
- presence of contraindications to labour such as placenta previa , Vasa previa,previous uterine surgery (e.g myomectomy ) that increases the risk of uterine rupture , previous C section
- history of antepartum hemorrhage
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 |
|---|---|---|
| 0.5mg PGE2 gelIn this interventional group patients presenting with PROM will be immediately induced by 0.5mg PGE2 gel. If bishop score will not improve after 6 hours, then application of PGE2 gel will be repeated (maximum 2 doses) | Drug | early induction of labour for PROM |
| 0.5mg PGE2 gelThe patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina. | Drug | Late induction of Labour in PROM |
Primary outcome
Duration of labour
Time frame: 24 hours
the duration of labour was assesed after each method of induction when patients presented with PROM
1 secondary outcome
Frequency of Normal Vaginal Delivery
Time frame: 24 hours
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 3 Dec 2025.
- Individual participant dataSharing planned: No. The participants have not given the cosent to share their personal data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5mg PGE2 gel in people with Prelabor Rupture of Membranes and Labor (Obstetrics)--Complications, run by Laiba Qamar at 1 site in Pakistan.
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 6 inclusion and 6 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 3 Dec 2025. 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 Pakistan. 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.
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?
Duration of labour (time frame: 24 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 3 Dec 2025.