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The Midlands and North of England Stillbirth Study (MiNESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025530
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : July 15, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Alexander Heazell, University of Manchester

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Stillbirth
Intervention Other: Questionnaire
Enrollment 1030
Recruitment Details Participants were recruited between April 2014 and March 2016 from 41 maternity units around the United Kingdom.
Pre-assignment Details 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.
Arm/Group Title Cases Controls
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 296 734
Completed 291 733
Not Completed 5 1
Reason Not Completed
No longer met elligibility criteria             5             1
Arm/Group Title Cases (Stillbirth) Controls (Live Pregnancy) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 291 733 1024
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 291 participants 733 participants 1024 participants
30.0  (5.9) 30.4  (5.1) 30.3  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 733 participants 1024 participants
Female
291
 100.0%
733
 100.0%
1024
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Maternal Sleep Practices During Pregnancy
Hide Description Self-reported going to sleep position in late pregnancy
Time Frame One night prior to questionnaire
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cases (Stillbirth) Controls (Live Pregnancy)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 291 733
Measure Type: Count of Participants
Unit of Measure: Participants
Left
140
  48.1%
383
  52.3%
Right
73
  25.1%
220
  30.0%
Back
19
   6.5%
24
   3.3%
Tummy
3
   1.0%
4
   0.5%
Propped
9
   3.1%
15
   2.0%
Variable
32
  11.0%
76
  10.4%
Unknown
15
   5.2%
11
   1.5%
2.Secondary Outcome
Title Maternal Perception of Fetal Activity
Hide Description Maternal Perception of Fetal Activity reported via the researcher-administered questionnaire.
Time Frame Two weeks prior to stillbirth / interview
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cases (Stillbirth) Controls (Live Pregnancy)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 291 733
Measure Type: Count of Participants
Unit of Measure: Participants
In last 2 weeks did movements increase?
37
  12.7%
254
  34.7%
In last 2 weeks did movements decrease?
86
  29.6%
63
   8.6%
Movements stayed the same
153
  52.6%
397
  54.2%
Unsure
15
   5.2%
19
   2.6%
3.Post-Hoc Outcome
Title Screening for Gestational Diabetes and Fasting Plasma Glucose
Hide Description Performance of 75g oral glucose tolerance test and the results of glucose tolerance test in cases and controls
Time Frame During index pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cases (Stillbirth) Controls (Live Pregnancy)
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 283 729
Measure Type: Count of Participants
Unit of Measure: Participants
Women screened by Oral Glucose Tolerance Test
94
  33.2%
277
  38.0%
Proportion Diagnosed with GDM
6
   2.1%
30
   4.1%
Time Frame For the duration of participation in the study (e.g. from recruitment until pregnancy outcome for participants in the control arm). As this was an observational study no SAEs were attributed to completion of the maternal questionnaire.
Adverse Event Reporting Description Stillbirth was not recorded as an adverse event in the case group because it was an entry criteria for the study.
 
Arm/Group Title Cases (Stillbirth) Controls (Live Pregnancy)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cases (Stillbirth) Controls (Live Pregnancy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/296 (0.00%)   0/734 (0.00%) 
Hide Serious Adverse Events
Cases (Stillbirth) Controls (Live Pregnancy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/296 (0.00%)   0/734 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cases (Stillbirth) Controls (Live Pregnancy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/296 (0.00%)   0/734 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Alexander Heazell
Organization: University of Manchester
Phone: +441612766484
EMail: alexander.heazell@manchester.ac.uk
Publications:
Layout table for additonal information
Responsible Party: Dr Alexander Heazell, University of Manchester
ClinicalTrials.gov Identifier: NCT02025530    
Other Study ID Numbers: GN2156
First Submitted: December 20, 2013
First Posted: January 1, 2014
Results First Submitted: December 3, 2018
Results First Posted: July 15, 2019
Last Update Posted: October 11, 2019