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 gestatio
Not Applicable
Completed
- Conditions
- Preterm prelabor rupture of the membranes (PPROM), homecare vs hospital carePregnancy and ChildbirthPreterm prelabor rupture of the membranes (PPROM)
- Registration Number
- ISRCTN44316210
- Lead Sponsor
- Helsinki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 126
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infectious events in mothers and in neonates during pregnancy and for 2 weeks after birth.
- Secondary Outcome Measures
Name Time Method <br> 1. Length of the pregnancy after PPROM<br> 2. Any events in the pregnancy after randomization<br> 3. Apgar scores at 1 min and 5 min after birth and pH values of the neonates<br> 4. Venous and arterial blood pH value for the neonate is measured using blood taken from the umbilical cord immediately after delivery<br> 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.<br>