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A double-blind randomized controlled trial of single-dose regimen versus two-dose regimen of azithromycin in pregnant women with preterm prelabour rupture of membranes (PPROM)

A double-blind randomized controlled trial of single-dose regimen versus two-dose regimen of azithromycin in pregnant women with preterm prelabour rupture of membranes (PPROM)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240820001
Enrollment
54
Registered
2024-08-20
Start date
2024-10-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Preterm prelabour rupture of membranes (PPROM) Preterm prelabour rupture of membranes (PPROM) Latency period Azithromycin Maternal complications Neonatal complications

Interventions

1. Ampicillin 2 g administered intravenously every 6 hours for 48 hours, followed by amoxicillin 250 mg administered orally every 8 hours for 5 days 2. Azithromycin 1 g administered orally once, follo
Placebo Comparator Drug,Experimental Drug
Group A,Group B

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Singleton pregnant women aged 18 years or older who were admitted to the labor room of the Department of Obstetrics and Gynaecology, Faculty of Medicine, Siriraj Hospital, with a diagnosis of preterm prelabour rupture of membranes (PPROM) at gestational age between 24 0/7 and 33 6/7 weeks.

Exclusion criteria

Exclusion criteria: - Intrauterine fetal demise - Multiple pregnancies - Major congenital fetal anomalies - History of hypersensitivity or allergy to penicillin or macrolides - Contraindications to expectant management, including clinical chorioamnionitis, placental abruption, nonreassuring fetal status, or advanced labor at the time of hospital admission (defined as active labour with cervical dilation of 4-6 cm or greater)

Design outcomes

Primary

MeasureTime frame
Latency period Duration between rupture of membranes to time of delivery (hours) Duration between rupture of membranes to time of delivery (hours)

Secondary

MeasureTime frame
Maternal adverse outcome after end of the intervention and postpartum period Number (case) of maternal adverse outcome,Neonatal adverse outcome Age of neonate between 0-28 days Number (case) of neonatal adverse outcome

Countries

Thailand

Contacts

Public ContactMinmanta Chinnawutsritrakul

Faculty of Medicine Siriraj Hospital, Mahidol University

minmanta_chin@hotmail.com0863422048

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026