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The safety of out-patient compared with in-patient treatment in women with preterm prelabor rupture of the membranes (PPROM) prior to 34 weeks of gestation

The safety of outpatient compared to inpatient treatment in women with PPROM prior to 34 weeks of gestation: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44316210
Enrollment
126
Registered
2018-05-11
Start date
2018-04-10
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

Preterm prelabor rupture of the membranes (PPROM), homecare vs hospital care Pregnancy and Childbirth Preterm prelabor rupture of the membranes (PPROM)

Interventions

Women with PPROM before 34+0 weeks of gestation are recruited to this study when they come to hospital. Everyone receives intravenous antibiotics for 3 consecutive days. Amniocentesis is performed to

Sponsors

Helsinki University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. PPROM at gestational weeks 20+0 to 33+6 2. No clinical signs of infection 3. No subclinical infection in amniocentesis 4. Willing to participate 5. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Severe Intrauterine growth restriction (IUGR) or redistribution in fetal blood flow 2. Symptomatic pre-eclampsia, or pre-eclampsia with blood pressure medication, proteinuria, or abnormal laboratory values 3. Clinical infection in vagina or uterus, or HIV infection 4. Inadequate language skills to understand the written medical consent or handout of the study 5. Diabetes Type 1

Design outcomes

Primary

MeasureTime frame
Infectious events in mothers and in neonates during pregnancy and for 2 weeks after birth.

Secondary

MeasureTime frame
1. Length of the pregnancy after PPROM 2. Any events in the pregnancy after randomization 3. Apgar scores at 1 min and 5 min after birth and pH values of the neonates 4. Venous and arterial blood pH value for the neonate is measured using blood taken from the umbilical cord immediately after delivery 4. Satisfaction of the mothers. The women will fill the first part of the satisfaction questionnaire immediately after randomization, and the second part at 34+0 weeks of gestation, when an individual plan for the delivery is made, or before that if the delivery starts spontaneously.

Countries

Finland

Outcome results

None listed

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