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Manual Versus Instrumental Rotation of the Fetal Head in Malposition at Birth (ROTATE Study): Protocol for a
Dawn Parris1, Raffaele Napolitano1, Jonathan Bishop2
1Maternal Fetal Medicine, Elizabeth Garrett Anderson (EGA) Institute for Women's Health, University College London, London, United Kingdom.
JMIR Research Protocols
|July 22, 2026
Summary
This randomized controlled trial (RCT) evaluated manual versus instrumental rotation for fetal malposition during birth. While recruitment challenges led to early closure, results are anticipated for severe perineal trauma and cesarean birth risks.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Surgical Innovation
Background:
- Fetal malposition at full cervical dilatation affects approximately 5% of women, increasing the likelihood of operative birth.
- Current evidence for rotational methods (Kielland forceps, vacuum, manual rotation) is limited to observational data.
- No randomized controlled trials (RCTs) comparing these rotational methods have been completed.
Purpose of the Study:
- To assess if manual rotation of the fetal head reduces severe maternal perineal trauma compared to instrumental rotation.
- To determine if manual rotation substantially increases the risk of cesarean birth at full dilatation.
Main Methods:
- The ROTATE trial was a pragmatic, multicenter, open-label RCT comparing manual versus instrumental rotation.
- The primary outcome was severe perineal trauma (third or fourth-degree tear); a coprimary outcome was cesarean birth at full dilatation.
- Recruitment involved 5200 participants across UK NHS maternity units, randomized 1:1 to manual or instrumental rotation.
Main Results:
- Data collection occurred from September 2022 to November 2024, recruiting 321 participants.
- Analysis of primary and secondary outcomes is currently ongoing.
- The trial closed early due to recruitment difficulties.
Conclusions:
- A multicenter RCT investigating rotational methods for fetal malposition was conducted in the UK.
- Despite early closure due to recruitment challenges, the trial's findings are highly anticipated.
- The study aimed to provide crucial evidence on the comparative effectiveness of manual versus instrumental rotation.
