Plain English Summary
Background and study aims
Premature birth can begin with contractions or with the premature breaking of the mother's waters (preterm prelabor rupture of the membranes, PPROM). About three or four of every ten deliveries start with PPROM. The most common reason for that is inflammation in the uterus (womb) or amniotic membranes (the double sac containing the baby and the amniotic fluid). PPROM does not always lead to immediate labor, so the pregnancy can go on for several weeks after PPROM. After PPROM there is an increased risk for chorioamnionitis (infection of the double membranes around the baby). Pregnant women who have had PPROM need to be monitored closely for signs of this infection. The current standard in Helsinki University Hospital is to follow up pregnancies after PPROM in the antenatal (pre-birth) ward. There is not enough research published on the need for hospital admission after PPROM in the absence of chorioamnionitis. The aim of this study is to examine if out-patient treatment after PPROM is as safe as in-patient treatment.
Who can participate?
Women with PPROM at 20-34 weeks of pregnancy with singleton pregnancy and no signs of infection or fetal distress.
What does the study involve?
Women with PPROM between 20+0 and 33+6 weeks of pregnancy coming to hospital are informed about the study. All women receive intravenous antibiotics for 3 consecutive days. Amniocentesis (taking some fluid from around the baby) is performed to rule out subclinical chorioamnionitis. After receiving more information and having given her consent, if a woman is eligible for a study, she will be randomized to out-patient or in-patient treatment until the birth oh her baby. In case of infection, the patient will be treated as the medical situation requires. The mother will fill in a questionnaire when she first joins the study and at 34 weeks of pregnancy after the birth if it is before 34 weeks.
What are the possible benefits and risks of participating?
There are no specific risks for those taking part in this study. Women who are randomized to the out-patient group can stay at home rather than stay in hospital several weeks after PPROM as in the usual treatment.
Where is the study run from?
Helsinki University Hospital
When is the study starting and how long is it expected to run for?
December 2017 to December 2020
Who is funding the study?
There is no additional funding needed to run the study
Who is the main contact?
Dr Tarja Myntti, tarja.myntti@hus.fi
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
HUS/456/2018
Study information
Scientific title
The safety of outpatient compared to inpatient treatment in women with PPROM prior to 34 weeks of gestation: a randomized controlled trial
Acronym
SAIKO
Study hypothesis
The safety of outpatient treatment in women with PPROM prior to 34 weeks of gestation is equivalent to the safety of inpatient treatment
Ethics approval(s)
Hospital district of Helsinki and Uusimaa Ethics committee for Women's and Children's Health and Psychiatry, 07/03/2018, HUS/456/2018
Study design
Randomised controlled single-center trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Finnish language information sheet available on request
Condition
Preterm prelabor rupture of the membranes (PPROM), homecare vs hospital care
Intervention
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.
Intervention type
Other
Primary outcome measure
Infectious events in mothers and in neonates during pregnancy and for 2 weeks after birth.
Secondary outcome measures
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.
Overall study start date
15/12/2017
Overall study end date
30/12/2020
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
126 (63 in each group)
Participant 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
Recruitment start date
10/04/2018
Recruitment end date
28/02/2020
Locations
Countries of recruitment
Finland
Study participating centre
Helsinki University Hospital and University of Helsinki
Haartmaninkatu 2
00290 Helsinki
Helsinki
00290
Finland
Sponsor information
Organisation
Helsinki University Hospital
Sponsor details
Haartmaninkatu 2
Helsinki
00290 HUS
Finland
Helsinki
00290
Finland
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Not defined
Funder name
Helsinki University Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
30/12/2020
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date .
IPD sharing plan summary
Stored in repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|