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Register:	ISRCTN
Last refreshed on:	21 January 2020
Main ID:	ISRCTN13114861
Date of registration:	22/04/2016
Prospective Registration:	No
Primary sponsor:	Birmingham Women's NHS Foundation Trust
Public title:	The optimal management in monochorionic twins (OMMIT) study
Scientific title:	Optimal Management in complicated Monochorionic Twins (OMMIT) Study
Date of first enrolment:	07/08/2015
Target sample size:	286
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN13114861
Study type:	Observational
Study design:	Observational single-centre study in two parts: a retrospective study (OMMIT 1) and a prospective study (OMMIT 2) (Screening)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:	Fiona Mackie
Address:	Academic Department O&G, 3rd Floor Birmingham Women's Hospital Mindelsohn Way B15 2TG Edgbaston United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
Retrospective study
Monochorionic diamniotic (MCDA) pregnancies for which trimester blood samples and outcome data have been stored.

Prospective study
Cohort S will be patients:
1. Booking at Birmingham Women's Clinic with an MCDA pregnancy confirmed on first-trimester ultrasound
2. Less than 20+6 weeks gestation at recruitment
3. Provide valid informed consent

Cohort C will be patients:
1. Referred to Birmingham Women's Hospital for treatment of a complication of monochorionic pregnancies
2. Provide valid informed consent

Exclusion criteria:
1. Unable to provide consent
2. Unable to confirm chorionicity

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Complications of monochorionic (MC) twin pregnancies including twin-twin transfusion syndrome (TTTS), twin anaemia-polycythaemia sequence (TAPS), selective intrauterine growth restriction (sIUGR) and single intrauterine fetal demise (sIUFD)
Pregnancy and Childbirth

Intervention(s)

There are two parts to this trial: a retrospective study and a prospective study.

In the retrospective study (OMMIT 1), markers of angiogenesis (blood vessel developmental) and placental function in the stored first-trimester blood samples will be analysed, these will then be combined with first-trimester ultrasound measurements and matched to outcome data to attempt to create a model.

In the prospective study (OMMIT 2), there will be 2 cohorts: Cohort S and Cohort C.
Cohort S will have blood samples taken at 12, 16 and 20 weeks gestation, their ultrasound measurements will be recorded and their outcomes collected. Cohort C will have a maternal blood sample pre- FLA and post-FLA. Amniotic fluid samples will be collected immediately pre-FLA and post-FLA, and ultrasound measurements. Researchers will use the results of the retrospective study to decide which biomarkers to investigate in the blood and amniotic fluid samples.
The following will then be compared:
1. "Normal" Cohort S blood samples to Cohort C samples
2. Cohort S samples longitudinally over the 3 time points
3. Cohort C pre-FLA and post-FLA blood and amniotic fluid samples

Primary Outcome(s)

Complication of MC pregnancy:
1. TTTS
2. Discordant growth
3. Selective IUGR
4. Single twin demise: <24 weeks, >24 weeks
5. Discordant chromosomal or structural anomaly
6. Neonatal mortality (until discharge)

These outcomes will be extracted from the hospital notes using a specially designed data collection form and recognised definitions of conditions where appropriate.

Secondary Outcome(s)

1. Antenatal complications (e.g. antepartum haemorrhage, small for gestational age, gestational diabetes, pre-eclampsia)
2. Maternal morbidity: (e.g. sepsis, hypertension, platelet or coagulation anomaly)
3. Gestation of delivery (If preterm <37 weeks iatrogenic or spontaneous)
4. Induction (or C/S) and precipitating cause
5. Mode of delivery (and reason)
6. Admission to NICU (and indication)
7. Composite measure of maternal morbidity
8. Composite measure of neonatal morbidity

These outcomes will be extracted from the hospital notes using a specially designed data collection form and recognised definitions of conditions where appropriate.

Secondary ID(s)

Source(s) of Monetary Support

The Richard and Jack Wiseman Trust, British Maternal and Fetal Medicine Society

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

1. East Midlands - Derby Research Ethics Committee, 09/06/2015, ref: 15/EM/0240 (OMMIT 1) 2. East Midlands - Derby Research Ethics Committee, 01/07/2015, ref: 15/EM/0244 (OMMIT 2)

Results

Results available:	Yes
Date Posted:
Date Completed:	01/10/2018
URL:

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