Premature Rupture of Membranes (PROM)NCT07802041
Planned Early Induction of Labor vs Expectant Management for PROM
A study testing Induction of labor with PGE2 and Expectant management in people with Premature Rupture of Membranes (PROM), run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to compare planned early induction of labor with expectant management in women with term premature rupture of membranes (PROM) at 37-42 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Premature Rupture of Membranes (PROM)
- What is being tested?
- Induction of labor with PGE2 and Expectant management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 734 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 18 to 45 years
- Singleton pregnancy on ultrasound
- Gestational age 37 to 42 weeks on LMP
- Any parity
- Premature rupture of membrane as per operational definition
Who cannot join
- H/o active infection.
- H/o placental abruption
- H/o preeclampsia
- Fetal anomalies on ultrasound
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Planned Early Induction of Labor Versus Expectant Management for Premature Rupture of Membranes
The goal of this randomized controlled trial is to compare planned early induction of labor with expectant management in women with term premature rupture of membranes (PROM) at 37-42 weeks of gestation. The main questions it aims to answer are:
Does planned early induction of labor reduce maternal and fetal complications compared with expectant management? Is there a difference in the frequency of cesarean section, chorioamnionitis, and fetal distress between the two management strategies? Researchers will compare active management (induction of labor within 24 hours) with expectant management (observation for 24 hours while awaiting spontaneous onset of labor).
Read more
Participants will:
Be women aged 18-45 years with singleton pregnancies and PROM at 37-42 weeks. Be randomly assigned to either active or expectant management. Receive routine monitoring and intravenous antibiotics until delivery. Be followed until delivery, with maternal and fetal outcomes recorded.
Read the detailed description
This randomized controlled trial will compare planned early induction of labor (active management) with expectant management in women with term premature rupture of membranes (PROM).
PROM is defined as rupture of the fetal membranes before the onset of labor. At term, the optimal timing of delivery remains an important clinical consideration because prolonged rupture of membranes may increase the risk of maternal and neonatal infection, while early delivery may increase interventions such as induction of labor and cesarean section.
The study will be conducted in the Department of Obstetrics and Gynaecology, PIMS Hospital, Islamabad, over a period of six months after approval of the synopsis. A total of 734 women will be enrolled using consecutive sampling and randomly allocated into two equal groups of 367 participants each.
Group A - Active Management:
Labor will be induced within 24 hours of diagnosis of PROM. Prostaglandin E2 vaginal gel (1 mg) will be used for cervical ripening/induction, with repeat doses at 6-hour intervals when required, up to a maximum of three doses.
Group B - Expectant Management:
Participants will undergo observation for 24 hours following diagnosis of PROM while awaiting spontaneous onset of labor. An endocervical swab will be collected for microscopy, culture, and sensitivity. Participants will be monitored for signs of infection and fetal compromise.
Both groups will receive intravenous antibiotics according to the study protocol (ceftriaxone 1 g every 24 hours and metronidazole 500 mg every 8 hours until delivery) and will be followed until delivery.
The study will compare maternal and fetal outcomes between the two groups, particularly:
Cesarean section Chorioamnionitis Fetal distress Baseline demographic and clinical characteristics, including age, gestational age, parity, BMI, socioeconomic status, educational level, and residential status, will also be recorded.
The purpose of the study is to determine whether planned early induction of labor or expectant management is associated with better maternal and fetal outcomes in women with term PROM.
- Conditions
- Premature Rupture of Membranes (PROM)
- Being tested
- Induction of labor with PGE2, Expectant management
- Keywords
- PROM, Chorioamnionitis, Cesearan section, Expectant management
- Medical subject headings
- Fetal Membranes, Premature Rupture, Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of labor with PGE2Procedure or surgery
Induction of labor within 24 hours of diagnosis of term PROM, using prostaglandin E2 vaginal gel as per study protocol.
Expectant managementBehavioural
Observation for 24 hours while awaiting spontaneous onset of labor, with maternal and fetal monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Active management | Experimental | Induction of labor within 24 hours of diagnosis of term premature rupture of membranes. Receives: Procedure: Induction of labor with PGE2 |
| Expectant management | Active comparator | Observation for 24 hours following diagnosis of term premature rupture of membranes while awaiting spontaneous onset of labor. Receives: Behavioral: Expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesearan section rate
Proportion of participants who undergo cesarean delivery in the active management group compared with the expectant management group.
Measured: From randomization until delivery
Chorioamnionitis
Proportion of participants developing clinical chorioamnionitis during labor or before delivery.
Measured: From randomization until delivery.
Fetal distress
Proportion of participants developing fetal distress during labor requiring intervention.
Measured: From randomization until delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 May 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
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 (PROM)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 734 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zohashaa Shahid, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802041
- Sponsor's protocol ID
- * F-5-2/2024(ERRC)/PIMS*
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Early Induction of Labor Versus Expectant Management for Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT07802041
- Acronym / sponsor ID
- * F-5-2/2024(ERRC)/PIMS*
- Conditions
- Premature Rupture of Membranes (PROM)
- Keywords
- PROM, Chorioamnionitis, Cesearan section, Expectant management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 734 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Sep 2026 (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.
The goal of this randomized controlled trial is to compare planned early induction of labor with expectant management in women with term premature rupture of membranes (PROM) at 37-42 weeks of gestation. The main questions it aims to answer are:
Does planned early induction of labor reduce maternal and fetal complications compared with expectant management? Is there a difference in the frequency of cesarean section, chorioamnionitis, and fetal distress between the two management strategies? Researchers will compare active management (induction of labor within 24 hours) with expectant management (observation for 24 hours while awaiting spontaneous onset of labor).
Participants will:
Be women aged 18-45 years with singleton pregnancies and PROM at 37-42 weeks. Be randomly assigned to either active or expectant management. Receive routine monitoring and intravenous antibiotics until delivery. Be followed until delivery, with maternal and fetal outcomes recorded.
Detailed description
This randomized controlled trial will compare planned early induction of labor (active management) with expectant management in women with term premature rupture of membranes (PROM).
PROM is defined as rupture of the fetal membranes before the onset of labor. At term, the optimal timing of delivery remains an important clinical consideration because prolonged rupture of membranes may increase the risk of maternal and neonatal infection, while early delivery may increase interventions such as induction of labor and cesarean section.
The study will be conducted in the Department of Obstetrics and Gynaecology, PIMS Hospital, Islamabad, over a period of six months after approval of the synopsis. A total of 734 women will be enrolled using consecutive sampling and randomly allocated into two equal groups of 367 participants each.
Group A - Active Management:
Labor will be induced within 24 hours of diagnosis of PROM. Prostaglandin E2 vaginal gel (1 mg) will be used for cervical ripening/induction, with repeat doses at 6-hour intervals when required, up to a maximum of three doses.
Group B - Expectant Management:
Participants will undergo observation for 24 hours following diagnosis of PROM while awaiting spontaneous onset of labor. An endocervical swab will be collected for microscopy, culture, and sensitivity. Participants will be monitored for signs of infection and fetal compromise.
Both groups will receive intravenous antibiotics according to the study protocol (ceftriaxone 1 g every 24 hours and metronidazole 500 mg every 8 hours until delivery) and will be followed until delivery.
The study will compare maternal and fetal outcomes between the two groups, particularly:
Cesarean section Chorioamnionitis Fetal distress Baseline demographic and clinical characteristics, including age, gestational age, parity, BMI, socioeconomic status, educational level, and residential status, will also be recorded.
The purpose of the study is to determine whether planned early induction of labor or expectant management is associated with better maternal and fetal outcomes in women with term PROM.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active management | Experimental | Procedure: Induction of labor with PGE2Induction of labor within 24 hours of diagnosis of term premature rupture of membranes. |
| Expectant management | Active comparator | Behavioral: Expectant managementObservation for 24 hours following diagnosis of term premature rupture of membranes while awaiting spontaneous onset of labor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age 18 to 45 years
- Singleton pregnancy on ultrasound
- Gestational age 37 to 42 weeks on LMP
- Any parity
- Premature rupture of membrane as per operational definition
Key exclusion criteria (4 listed)
- H/o active infection.
- H/o placental abruption
- H/o preeclampsia
- Fetal anomalies on ultrasound
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 |
|---|---|---|
| Induction of labor with PGE2Induction of labor within 24 hours of diagnosis of term PROM, using prostaglandin E2 vaginal gel as per study protocol. | Procedure or surgery | Active management |
| Expectant managementObservation for 24 hours while awaiting spontaneous onset of labor, with maternal and fetal monitoring. | Behavioural | Expectant management |
Primary outcome
Cesearan section rate
Time frame: From randomization until delivery
Proportion of participants who undergo cesarean delivery in the active management group compared with the expectant management group.
Chorioamnionitis
Time frame: From randomization until delivery.
Proportion of participants developing clinical chorioamnionitis during labor or before delivery.
Fetal distress
Time frame: From randomization until delivery.
Proportion of participants developing fetal distress during labor requiring intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Induction of labor with PGE2 and Expectant management in people with Premature Rupture of Membranes (PROM), run by Pakistan Institute of Medical Sciences 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cesearan section rate (time frame: From randomization until delivery). The study lists 3 primary outcomes in all. 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 Sep 2026.