Trial Outcomes & Findings for The Midlands and North of England Stillbirth Study (NCT NCT02025530)

NCT ID: NCT02025530

Last Updated: 2019-10-11

Results Overview

Self-reported going to sleep position in late pregnancy

• Recruitment status: COMPLETED
• Target enrollment: 1030 participants
• Primary outcome timeframe: One night prior to questionnaire
• Results posted on: 2019-10-11

Participant Flow

Participants were recruited between April 2014 and March 2016 from 41 maternity units around the United Kingdom.

This was a case-control study, so participants were not assigned to a specific arm/group. 5 cases (women who had a stillbirth) were excluded prior to analysis because the baby was found to have a congenital anomaly at post-mortem examination. One control (women with a live baby at interview) was excluded because she had a stillborn baby.

Participant milestones

Measure	Cases A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
Overall Study STARTED	296	734
Overall Study COMPLETED	291	733
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	Cases A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
Overall Study No longer met elligibility criteria	5	1

Baseline Characteristics

The Midlands and North of England Stillbirth Study

Baseline characteristics by cohort

Measure	Cases (Stillbirth) n=291 Participants A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls (Live Pregnancy) n=733 Participants A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Total n=1024 Participants Total of all reporting groups
Age, Continuous	30.0 years STANDARD_DEVIATION 5.9 • n=5 Participants	30.4 years STANDARD_DEVIATION 5.1 • n=7 Participants	30.3 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	291 Participants n=5 Participants	733 Participants n=7 Participants	1024 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One night prior to questionnaire

Self-reported going to sleep position in late pregnancy

Outcome measures

Measure	Cases (Stillbirth) n=291 Participants A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls (Live Pregnancy) n=733 Participants A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
Maternal Sleep Practices During Pregnancy Left	140 Participants	383 Participants
Maternal Sleep Practices During Pregnancy Right	73 Participants	220 Participants
Maternal Sleep Practices During Pregnancy Back	19 Participants	24 Participants
Maternal Sleep Practices During Pregnancy Tummy	3 Participants	4 Participants
Maternal Sleep Practices During Pregnancy Propped	9 Participants	15 Participants
Maternal Sleep Practices During Pregnancy Variable	32 Participants	76 Participants
Maternal Sleep Practices During Pregnancy Unknown	15 Participants	11 Participants

SECONDARY outcome

Timeframe: Two weeks prior to stillbirth / interview

Maternal Perception of Fetal Activity reported via the researcher-administered questionnaire.

Outcome measures

Measure	Cases (Stillbirth) n=291 Participants A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls (Live Pregnancy) n=733 Participants A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
Maternal Perception of Fetal Activity In last 2 weeks did movements increase?	37 Participants	254 Participants
Maternal Perception of Fetal Activity In last 2 weeks did movements decrease?	86 Participants	63 Participants
Maternal Perception of Fetal Activity Movements stayed the same	153 Participants	397 Participants
Maternal Perception of Fetal Activity Unsure	15 Participants	19 Participants

POST_HOC outcome

Timeframe: During index pregnancy

Population: Women were excluded from this analysis if they had pre-existing diabetes. Women should have been screened using oral glucose tolerance test if they had a positive family history, were of South Asian or Black Caribbean ethnicity, had a body mass index ≥ 30 kg/m2, or previous pregnancy effected by GDM or macrosomic (birthweight ≥4.5 kg) birth.

Performance of 75g oral glucose tolerance test and the results of glucose tolerance test in cases and controls

Outcome measures

Measure	Cases (Stillbirth) n=283 Participants A structured questionnaire was administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.	Controls (Live Pregnancy) n=729 Participants A structured questionnaire was administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality. Questionnaire: An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls. Clinical information was obtained from maternal case notes following the interview.
Screening for Gestational Diabetes and Fasting Plasma Glucose Women screened by Oral Glucose Tolerance Test	94 Participants	277 Participants
Screening for Gestational Diabetes and Fasting Plasma Glucose Proportion Diagnosed with GDM	6 Participants	30 Participants

Adverse Events

Cases (Stillbirth)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls (Live Pregnancy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Alexander Heazell

University of Manchester

Phone: +441612766484

Email: alexander.heazell@manchester.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place