A Study Comparing the Two standard Medicines Used to Start Labour in Pregnant Women When the Water Breaks Early After 34 Weeks

Labor Induction for Premature Rupture of Membranes Using Vaginal Misoprostol versus Dinoprostone gel beyond 34 weeks of gestation - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106025

Enrollment

100

Registered

2026-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Vaginal Misoprostol versus Dinoprostone Gel: Vaginal misoprostol ___ As per the standard guidelines micrograms (e.g., 25 mcg) inserted into the posterior fornix every ___ hours (e.g., e

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women more than and equal to 34+0 weeks and less than and equal to 41 weeks gestation Singleton pregnancy in cephalic presentation Confirmed PROM by history and on sterile speculum examination Intact maternal and fetal status at admission No contraindication to vaginal delivery

Exclusion criteria

Exclusion criteria: Previous cesarean section or major uterine surgery Suspected chorioamnionitis at presentation Non-cephalic fetal presentation Placenta previa or vasa previa Known hypersensitivity to prostaglandins Severe fetal compromise requiring immediate delivery Polyhydramnios or oligohydramnios requiring alternative management Multiple gestation

Design outcomes

Primary

Measure	Time frame
1.shorter induction to active labour stage 2.Shorter induction-to-delivery interval 3.Lower rates of cesarean section 4.Reduced maternal and neonatal complications 5.Higher overall induction success Timepoint: 1.To see from the drug administration until the onset of active labour. 2.From drug administration until the delivery. 3.Assessed at the time of delivery. 4.Assessed during labour and within the first 24 hours after delivery. 5.Assessed at the completion of delivery.	—

Measure

Time frame

1.shorter induction to active labour stage 2.Shorter induction-to-delivery interval 3.Lower rates of cesarean section 4.Reduced maternal and neonatal complications 5.Higher overall induction success Timepoint: 1.To see from the drug administration until the onset of active labour. 2.From drug administration until the delivery. 3.Assessed at the time of delivery. 4.Assessed during labour and within the first 24 hours after delivery. 5.Assessed at the completion of delivery.

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Secondary

Measure	Time frame
.Mode of delivery (vaginal / cesarean) Indication for cesarean (if any) .Chorioamnionitis (Yes / No; clinical / confirmed) .Postpartum hemorrhage (Yes / No; amount) .Analgesia / Epidural use (Yes / No) .Induction failure (defined as no labor after set time?) AND Neonatal Outcomes: Birth weight Apgar score at 1 min, 5 min Neonatal sepsis (clinical / lab) NICU admission (Yes / No) Neonatal infection (culture positive or suspected) Duration of NICU stay (if admitted) Timepoint: At delivery At time of cesarean During labor or within 24 hrs postpartum Within 24 hrs after delivery During labor Assessed after defined induction period 24 hrs after induction start if no active labour Birth weight Immediately after birth Apgar score at 1 & 5 minutes after birth Neonatal sepsis within first 72 hrs of life or during hospital stay NICU admission Immediately after birth Neonatal infection During neonatal hospital stay from NICU admission to discharge	—

Measure

Time frame

.Mode of delivery (vaginal / cesarean) Indication for cesarean (if any) .Chorioamnionitis (Yes / No; clinical / confirmed) .Postpartum hemorrhage (Yes / No; amount) .Analgesia / Epidural use (Yes / No) .Induction failure (defined as no labor after set time?) AND Neonatal Outcomes: Birth weight Apgar score at 1 min, 5 min Neonatal sepsis (clinical / lab) NICU admission (Yes / No) Neonatal infection (culture positive or suspected) Duration of NICU stay (if admitted) Timepoint: At delivery At time of cesarean During labor or within 24 hrs postpartum Within 24 hrs after delivery During labor Assessed after defined induction period 24 hrs after induction start if no active labour Birth weight Immediately after birth Apgar score at 1 & 5 minutes after birth Neonatal sepsis within first 72 hrs of life or during hospital stay NICU admission Immediately after birth Neonatal infection During neonatal hospital stay from NICU admission to discharge

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Countries

India

Contacts

Public ContactDr Yapi Marging

aiims guwahati

yapimarging87099@gmail.com8119007028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026