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Abstract
Objective: C-STICH2 is a randomised controlled trial of emergency cervical cerclage (ECC) vs routine care in women who present in pregnancy with premature cervical dilatation and exposed unruptured fetal membranes. Within the proposed trial an internal pilot was performed with an embedded qualitative process evaluation (QPE) to explore the feasibility of recruitment. The QPE aimed to collect and analyse data exploring the experiences of health care professionals (HCPs) involved in recruitment, and women approached about the trial.
Methods: Semi-structured interviews (telephone or face-to-face) were held with eligible participants who had consented to participate in the QPE. Interviews were audio-recorded, transcribed, and analysed to identify main themes. Interview transcripts were analysed using qualitative thematic analysis (QTA).
Results: 11 women and 23 HCPs were interviewed. Three super-ordinate themes of Fluidity of Equipoise, A Complex Obstetric History, and the Influence of Gestation were identified. Within these, the five main themes which influenced trial participation were: 1) Complex decision-making processes; 2) Predicting outcomes; 3) The importance of terminology and initial RCT approach; 4) Women’s understanding of the need for research in this area; 5) Changes in practice which are trial influenced.
Conclusions: For both HCPs and women and their families, there was a conflation of the potential risks and outcomes of ECC with those of elective cerclage and the complexity around ECC placement was not always well understood by those with less experience and understanding of the intervention. Decision making was shown to be complex and multi-factorial for both HCPs and women. For complex trials in rare conditions with treatment uncertainty, clinical equipoise is likely to be fluid and influenced by multiple factors.
Methods: Semi-structured interviews (telephone or face-to-face) were held with eligible participants who had consented to participate in the QPE. Interviews were audio-recorded, transcribed, and analysed to identify main themes. Interview transcripts were analysed using qualitative thematic analysis (QTA).
Results: 11 women and 23 HCPs were interviewed. Three super-ordinate themes of Fluidity of Equipoise, A Complex Obstetric History, and the Influence of Gestation were identified. Within these, the five main themes which influenced trial participation were: 1) Complex decision-making processes; 2) Predicting outcomes; 3) The importance of terminology and initial RCT approach; 4) Women’s understanding of the need for research in this area; 5) Changes in practice which are trial influenced.
Conclusions: For both HCPs and women and their families, there was a conflation of the potential risks and outcomes of ECC with those of elective cerclage and the complexity around ECC placement was not always well understood by those with less experience and understanding of the intervention. Decision making was shown to be complex and multi-factorial for both HCPs and women. For complex trials in rare conditions with treatment uncertainty, clinical equipoise is likely to be fluid and influenced by multiple factors.
| Original language | English |
|---|---|
| Pages (from-to) | 27-39 |
| Number of pages | 13 |
| Journal | European Journal of Obstetrics & Gynecology and Reproductive Biology |
| Volume | 279 |
| Early online date | 6 Oct 2022 |
| DOIs | |
| Publication status | Published - 1 Dec 2022 |
Bibliographical note
Funding Information:CSTICH-2 Pilot Trial was funded by the NIHR HTA (ID No: 16/151/01).
Funding Information:
Professor Katie Morris , Reader Maternal and Fetal Health, University of Birmingham, Director Birmingham Clinical Trials Unit. Her research aims to improve the care for women with multiple pregnancies, fetal anomalies, growth restriction, reducing infection in maternity and prevention of preterm birth, employing prognostic and diagnostic research, modelling, systematic reviews and clinical trials. She has received research funding from the HTA, RfPB, MRC and charities. She sits on the RCOG Research Committee and Scientific Advisory Committee, RfPB West Midlands Panel, Wellbeing of Women Scientific Advisory Committee, British Maternal and Fetal Medicine Society Executive Committee as President and is Clinical Speciality Lead for Reproductive Health and Childbirth for the West Midlands. Her clinical practice is at Birmingham Women’s and Children’s Hospital NHS Foundation Trust where she cares for women with complex pregnancies including maternal cardiac disease, fetal growth restriction and multiple pregnancies including providing fetal therapy. She is lead for the Women’s and Children’s Health theme of Birmingham Health Partners.
Publisher Copyright:
© 2022 The Author(s)
Keywords
- Randomised Controlled Trials
- Emergency cervical cerclage
- Pre-term Birth
- High-risk pregnancy
- Qualitative process evaluation
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Rescue Cervical Cerclage to prevent miscarriage and preterm birth a Randomised Controlled Trial (C-STICH2)
Brocklehurst, P., Morton, V., Middleton, L., Coomarasamy, A., Morris, K., Jones, L., Thangaratinam, S. & Moakes, C.
NIHR EVALUATION, TRIALS AND STUDIES COORDINATING CENTRE
1/07/18 → 30/04/26
Project: Other Government Departments