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Effect of Betamethasone in mothers with PROM

Evaluation of the effect of a complete course of betamethasone on neonatal and mothers with Premature rupture of membranes at 34 to 36 weeks of pregnancy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221010056141N1
Enrollment
200
Registered
2022-12-20
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Premature Rupture of Membrane. Premature rupture of membranes

Interventions

Intervention 1: Mothers with premature rupture of membrane between 34 to 36 weeks of gestational age, in which betamethasone ampoule with a dose of 12 mg (3 ampoules of 4 mg at once) is injected intra

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Mothers with Premature rupture of membranes At 34 to 36 weeks of pregnancy Singleton pregnancy

Exclusion criteria

Exclusion criteria: Symptoms of chorioamnionitis in mother:fever, tachycardia Infants small for gestational age Infants large for gestational age Any indication of emergency termination confirmed by fetal assessment Maternal diabetes Passing more than 48 hours from rupture of membrane

Design outcomes

Primary

MeasureTime frame
RDS Score. Timepoint: after birth of neonate. Method of measurement: Completion of RDS Score with inspection and auscultation.;APGAR Score. Timepoint: 1 and 5 minute after birth. Method of measurement: inspection of neonate.;Need for Surfactant administration. Timepoint: during first 3 day of life. Method of measurement: medical record of neonate.;Maternal chorioamniotitis. Timepoint: since rupture of membrane till 48 hours after delivery, every 6 hours. Method of measurement: existence of clinical signs : fever and tachycardia.

Secondary

MeasureTime frame
Local infection of mother. Timepoint: One week till one month after delivery. Daily during hospitalization and weekly after discharge. Method of measurement: Observation of c section incision and perineum of mother and assessment for infection signs.;Neonatal death. Timepoint: 28 days after birth. Method of measurement: neonatal medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Naeiji

Shahid Beheshti University of Medical Sciences

zahrabahman77@yahoo.com+98 21 5506 2628

Outcome results

None listed

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