Bed Rest With a Short Cervix on Preterm Birth (BEWISE)
BEWISE - Bed Rest With a Short Cervix on Preterm Birth
Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.
The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.
The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).
The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.
Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.
Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.
The primary outcome is gestational age in days (continuous).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kirsten Bünemann, Medical Doctor, PhD-student
- 전화번호: +45 40329849
- 이메일: kirsten.bunemann@clin.au.dk
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Pregnant women with gestational age 20+0 to 33+6
- Cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnancies
- Above 18 years of age
- Reads and understands Danish or English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Activity Restriction
The comparison arm reflects current Danish clinical practice in each participating region.
According to national recommendations, AR is indicated before GA 28+0, with the level of restriction determined by cervical length and clinical context.
In singleton pregnancies with a cervix <10 mm in singleton/<15 mm in twins, strict AR is prescribed, defined as bed rest with only toilet allowance.
In addition, thrombosis prophylaxis (Low Molecular Weight Heparin and compression stockings) is initiated in cases of strict AR.
In women with a cervix of 10-14 mm in singletons/15-20 mm in twins, or in cases of PPROM with a cervix <25 mm, moderate AR is prescribed, defined as 2-8 hours of daily bed rest.
The regimen is continued until 28 weeks of gestation.
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Recommendation to restrict physical activity in pregnant women with a short cervix.
This may include increased rest or bed rest according to local clinical practice.
다른 이름들:
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실험적: No Activity Restriction
The intervention consists of a recommendation of NAR during pregnancy. No general or graded restrictions on daily activities are advised, and cervical length is not an indication for activity limitation, in line with current evidence. The NAR recommendation is supported by a pragmatic clinical guidance. Women are advised to avoid activities that provoke pain, increase uterine contractions, or worsen pelvic pressure. Decisions regarding hospital admission or sick leave are based on individual clinical assessment rather than cervical length. Specific advice may be provided when clinically indicated. Women are generally advised to avoid heavy weight-bearing exercise and lifting of objects exceeding approximately 10 kg. Otherwise, no specific restrictions on physical activity are imposed, provided that activities do not provoke symptoms such as pain, increased uterine contractions, or pelvic pressure. Sexual activity may be ad-dressed on an individual basis following clinical assessment. |
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gestational age at birth
기간: At birth (from inclusion until delivery)
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Gestational age at birth measured in completed days of pregnancy.
This is calculated based on the estimated due date from ultrasound (crown-rump lenght <14weeks).
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At birth (from inclusion until delivery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Birth before 37 weeks of gestation
기간: At birth
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At birth
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Gestational age at birth, pooled
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Latency from inclusion to birth (days)
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Onset of birth
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Mode of birth
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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- Non-occipital presentation
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Interventions during birth
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Degree of birth tear
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Maternal serious morbidity
기간: From inclusion to 42 days after delivery
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Admission to an intensive care unit or a unit providing 24-hour medical supervision, mechanical ventilation, or continuous vasoactive drug support at any time during pregnancy and postpartum due to pregnancy- or childbirth-related complications
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From inclusion to 42 days after delivery
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Umbilical cord arterial pH
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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EPDS depression score
기간: From inclusion to 8 weeks after due date
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From inclusion to 8 weeks after due date
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Bone turnover marker level
기간: At inclusion and after 4 and 8 weeks.
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At inclusion and after 4 and 8 weeks.
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Lumbar spine Z-score
기간: 12 months after stopped breastfeeding
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12 months after stopped breastfeeding
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Data from SENS activity tracker
기간: At birth (from inclusion until delivery)
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Step count Time in supine position
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At birth (from inclusion until delivery)
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Neonatal mortality
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Fetal loss
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Birth weight
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Neonatal admission, days
기간: From inclusion until discharge or 44 postmenstrual weeks
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From inclusion until discharge or 44 postmenstrual weeks
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CNS morbidity
기간: From inclusion until discharge or 44 postmenstrual weeks
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Intraventricular haemorrhage grade III or IV, Periventricular leukomalacia
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From inclusion until discharge or 44 postmenstrual weeks
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Gastrointestinal morbidity
기간: From inclusion until discharge or 44 postmenstrual weeks
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Necrotizing enterocolitis (NEC) requiring surgery (Bell's stage 3), Spontaneous intestinal perfo-ration (SIP) requiring surgical treatment
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From inclusion until discharge or 44 postmenstrual weeks
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Respiratory support
기간: From inclusion until discharge or 44 postmenstrual weeks
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Mechanical ventilation or non-invasive ventilation (NIV)
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From inclusion until discharge or 44 postmenstrual weeks
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Respiratory distress syndrome (RDS)
기간: From inclusion until discharge or 44 postmenstrual weeks
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From inclusion until discharge or 44 postmenstrual weeks
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Early onset infection
기간: From inclusion to 5 days after birth
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Definition: >5 days of i.v.
antibiotics where the treatment starts within the first week after delivery.
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From inclusion to 5 days after birth
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Apgar score at 5 minutes
기간: At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Julie Glavind, Senior Consultant, MD, PhD, Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16-0500-15
- 4308-00216B (기타 보조금/기금 번호: Independent Research Fund Denmark)
- 1-10-72-96-25 (기타 식별자: De Videnskabsetiske Komitéer For Region Midtjylland)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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