PLANES - placental growth factor led management of the small for gestational age fetus: a feasibility study

Not Applicable

• Conditions: Small for gestational age fetus; Pregnancy and Childbirth

• Registration Number: ISRCTN58254381
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 21 March 2022
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Women with a SGA fetus between 32+0 and 37+6 weeks of gestation
2. Singleton pregnancy
3. Age =16 years
4. 32+0 – 37+6 weeks of gestation
5. EFW <10th centile on ultrasound within preceding 72 hours

Exclusion Criteria

1. Unable to give informed consent
2. Known or suspected structural/chromosomal fetal abnormality
3. Absent or reversed EDF in Umbilical Artery on Doppler study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The feasibility of using a maternal biomarker (sFlt-1/PIGF ratio) to refine the care pathway for the management of pregnancies affected by SGA including:<br> 1. Recruitment rate recorded as the number of eligible women who consent to participate in the study during the 12 month recruitment period<br> 2. Attrition rate assessed using the number of women who consent to participate and remain in the study until hospital discharge or their due date, whichever is sooner<br> 3. Acceptability of biomarker led management to women and clinicians assessed by interviews/questionnaires (PLANES Women and Partner Questionnaire) with women and their birth partners following the consent process and clinician focus groups at the end of the 12-month recruitment period<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures