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A Study to Evaluate Foeto-Maternal Outcomes in Pregnant Women with Premature Rupture of Membranes and Preterm Premature Rupture of Membranes at a Single Hospital

Prospective, Observational, Single center study to evaluate the foeto-maternal outcomes in Premature Rupture of Membranes and Preterm Premature Rupture of Membranes. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093660
Enrollment
86
Registered
2025-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women with confirmed PROM (spontaneous rupture of membranes before the onset of labor). 2. Singleton pregnancies. 3. Gestational age more then or equal to 28 weeks. 4. Women willing to participate and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Gestational age less than 28 weeks 2. Post caesarean pregnancy 3. Multiple pregnancies 4. Malpresentation 5. Ante partum haemorrhage 6. Meconium stained liquor 7. Congenital anomalies 8. Pregnant women with pre-existing maternal infections (e.g., HIV, active tuberculosis).

Design outcomes

Primary

MeasureTime frame
Maternal and neonatal outcomes will be monitored from admission until discharge, including maternal complications such as chorioamnionitis, postpartum hemorrhage, maternal sepsis, and cesarean delivery, as well as neonatal outcomes like sepsis, NICU admissions, low Apgar scores, preterm birth, respiratory distress syndrome, and perinatal mortality.Timepoint: 1 hour after the admission, 1 hour before discharge—

Secondary

MeasureTime frame
1. Duration from PROM to delivery & its impact on maternal & neonatal outcomes. 2. Mode of delivery (vaginal vs. cesarean section) & associated maternal morbidity. 3. Need for antenatal corticosteroids & its effect on neonatal respiratory outcomes in preterm PROM. 4. Prophylactic antibiotics (cefotaxime 1 gm BD & metronidazole 500 gms BD) use & its effectiveness in preventing maternal & neonatal infections. 5. Comparison of maternal & neonatal outcomes between term PROM (equal to or more then 37 weeks) & preterm PROM (less than 37 weeks). Timepoint: 1 hour after the admission, 1 hour before discharge—

Countries

India

Contacts

Public ContactDR Vaishali Choudhri

Bhaktivedanta hospital and Research institute

drvaishali231980@gmail.com9321996831

Outcome results

None listed

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