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

• Register: ISRCTN
• Last refreshed on: 16 January 2023
• Main ID: ISRCTN44316210
• Date of registration: 11/05/2018
• Prospective Registration: No
• Primary sponsor: Helsinki University Hospital
• Public title: 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
• Scientific title: The safety of outpatient compared to inpatient treatment in women with PPROM prior to 34 weeks of gestation: a randomized controlled trial
• Date of first enrolment: 10/04/2018
• Target sample size: 126
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN44316210
• Study type: Interventional
• Study design: Randomised controlled single-center trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Finland

Contacts

• Name: Tarja Myntti

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 rule out intra-amniotic infection.
Randomization is performed by picking closed, opaque envelope from the box. The envelope includes a paper with a text "home treatment" or "hospital treatment".
Out-patient treatment:
Women are sent home, and they will have check-ups at hospital twice a week during the first 2 weeks, and after that once a week. At every visit cardiotocography (CTG), C-reactive protein (CRP) and leukocyte values are checked, and once a week a doctor will examine the cervix and perform an abdominal ultrasound examination. At home they measure their temperature and contact the hospital if they have a fever, the baby is not moving, they have odorous discharge from the cervix, or they start to have regular contractions.
In-patient treatment:
Daily CTG, daily point-of-care CRP testing. Ultrasound examination, laboratory leukocyte count and hemoglobin once a week. Individual plan for delivery at gestational age 34+0, or before, if any signs or symptoms of clinical chorioamnionitis. In-patients can move around the ward freely if the length of cervical canal is >10 mm.

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

HUS/456/2018

Source(s) of Monetary Support

Helsinki University Hospital

Ethics review

Status:
Approval date:
Contact:

Hospital district of Helsinki and Uusimaa Ethics committee for Women's and Children's Health and Psychiatry, 07/03/2018, HUS/456/2018

Results

• Results available: Yes
• Date Completed: 30/12/2020