Condition category
Pregnancy and Childbirth
Date applied
07/05/2018
Date assigned
11/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tarja Myntti

ORCID ID

Contact details

Naistenklinikka
Haartmaninkatu 2
7. krs
00290 Helsinki
Finland
Helsinki
00290
Finland

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

15/12/2017

Overall trial end date

30/12/2020

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date .

Intention to publish date

30/12/2020

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes