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Evaluating the effectiveness of lateral postural management for breech presentation: study protocol for a randomized
Hiroki Shinmura1, Takashi Matsushima2, Asako Watanabe2
1Department of Obstetrics and Gynecology, Nippon Medical School Musashikosugi Hospital, 1-383 Kosugicho, Nakahara-Ku, Kawasaki-Shi, Kanagawa, 211-8533, Japan. h-shimmura@nms.ac.jp.
Trials
|May 27, 2023
Summary
This study investigates if a simple lateral position technique can effectively convert breech presentation to cephalic presentation before 36 weeks, potentially offering a safe, non-invasive treatment option for pregnant individuals.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Clinical Trial Methodology
Background:
- Breech presentation occurs in 3-4% of term pregnancies, frequently necessitating cesarean delivery.
- Currently, no established treatments exist for breech presentation before 36 weeks gestation.
- Previous retrospective studies suggest lateral positioning may be effective, but lacked randomized controlled trial evidence.
Purpose of the Study:
- To evaluate the efficacy of a lateral positioning technique for correcting breech presentation in the third trimester.
- To compare lateral position management against expectant management for achieving cephalic presentation.
- To assess the impact on cesarean delivery rates and other secondary outcomes.
Main Methods:
- An open-label, randomized controlled trial (BRLT study) enrolling 200 patients with breech presentation between 28+0 and 30+0 weeks.
- Intervention group: instructed to lie on their side for 15 minutes, three times daily, based on fetal back position.
- Primary outcome: cephalic presentation at term. Secondary outcomes include cesarean delivery, recurrent breech, and adverse effects.
Main Results:
- Primary outcome data on cephalic presentation at term is pending trial completion.
- Secondary outcome data collection includes cesarean delivery rates and presentation at 2, 4, and 6 weeks post-intervention.
- Adverse effects and recurrent breech presentation rates are also being monitored.
Conclusions:
- This randomized controlled trial aims to determine if lateral positioning is an effective treatment for breech presentation.
- Positive findings could establish a simple, safe, and less painful non-invasive option for managing breech presentation before 36 weeks.
- The study's results may significantly influence current clinical practice for breech presentation management.
