Monochorionic (MC) twin pregnancies with early-onset (prior to 24 weeks) selective fetal growth restriction (sFGR) Pregnancy and Childbirth
Conditions
Interventions
A mixed-methods study has been designed to explore the current management of sFGR in MC twin pregnancy. This information will be used to inform a subsequent RCT comparing management options
intervention versus expectant management.
The study design involves 3 work packages, 1) a prospective UK multicentre study, 2) a qualitative study of women's and clinical staff's views and 3) an int
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. MC diamniotic twin pregnancy 2. Diagnosis of sFGR (EFW of one twin 25%) 3. Gestational age at diagnosis between 16+0 - 23+6 weeks based on ultrasound 4. Informed consent given by the participant and the consent form completed and signed
Exclusion criteria
Exclusion criteria: 1. Singleton pregnancies 2. Maternal age under 18 years 3. TTTS 4. Twin anaemia polycythaemia sequence before enrolment 5. Other rare complicated MC twin pregnancies, such as twin reversed arterial perfusion syndrome 6. Known karyotype abnormality at enrolment 7. Known major fetal structural abnormality at enrolment, defined as a lethal, incurable or curable severe abnormality with a high risk of residual handicap 8. Indication for immediate delivery 9. Pre-term pre-labour rupture of membranes before enrolment 10. Women who lack the capacity to give informed consent 11. Any medical condition that compromises the woman’s ability to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of conducting an RCT of active intervention versus expectant management in MC twin pregnancies with early-onset (prior to 24 weeks) sFGR will be measured using the following methods within the approved study timeline: Work Package 1 - A collection of prospective data on the management and clinical outcomes of MC pregnancies complicated by sFGR (data collection from prospective eligible pregnancies from informed consent date to date of maternal discharge) Work Package 2 - Perform a qualitative study involving interviews and focus groups with parents and clinicians to explore trial design, acceptability, feasibility and decision-making related to intervention or expectant management (qualitative interviews and focus groups) Work Package 3 - Using information provided in work packages 1 and 2 to develop a consensus on a future definitive study (questionnaire and focus groups) | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactTracey Ricketts
Outcome results
None listed