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The optimal management in monochorionic twins (OMMIT) study

Optimal Management in complicated Monochorionic Twins (OMMIT) Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13114861
Enrollment
286
Registered
2016-04-22
Start date
2015-08-07
Completion date
Unknown
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 placen

Sponsors

Birmingham Women's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Complication of MC pregnancy: 1. TTTS 2. Discordant growth 3. Selective IUGR 4. Single twin demise: 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

MeasureTime frame
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.

Countries

United Kingdom

Contacts

Public ContactFiona Mackie

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026