Table 2 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identifying number | UMIN000043613 |
Date of registration in primary registry | 15 March 2021 |
Secondary identifying numbers | R000049800, 599–2-64 |
Source of monetary or material support | None, self-funding |
Sponsor | None |
Contact for public queries | Hiroki Shinmura MD, h-shimmura@nms.ac.jp |
Contact for scientific queries | Hiroki Shinmura MD, Department of Obstetrics and Gynecology, Kawasaki, Japan |
Public title | A randomized controlled trial of cephalic version for breech presentation in the third trimester by lateral postural management without knee-chest position (BRLT) |
Scientific title | A randomized controlled trial of cephalic version for breech presentation in the third trimester by lateral postural management without knee–chest position |
Countries of recruitment | Japan |
Health condition or problem studied | Breech presentation |
Interventions | Interventions: Women of the interventional group are going to be instructed to lie on their right side several times a day when the fetal back was left side, or to lie on their left side when the fetal back was right side. After cephalic version, they are going to be instructed the other side. Other genupectoral management is not recommended |
| Â | Control: Women of the control group are going to receive expectant management care complying with Guidelines for obstetrical practice in Japan 2020 |
Key inclusion and exclusion criteria | Inclusion criteria: Women who are diagnosed with breech presentation by ultrasonography between 28Â weeks 0Â days and 30Â weeks 0Â days of gestation at a single institution were eligible for inclusion |
| Â | Exclusion criteria: The exclusion criteria were scheduled cesarean delivery (included placenta previa, history of cesarean delivery, and history of myomectomy), multiple pregnancy, transverse position, scheduled delivery at another hospital, other genupectoral management, and complications such as heart disease |
Study type | Interventional |
|  | Allocation: randomized; intervention model: parallel assignment; masking: open—no one is blinded |
| Â | Primary purpose: |
| Â | Phase III |
Date of first enrolment | April 2021 |
Target sample size | 200 |
Recruitment status | Recruiting |
Primary outcome | The percentage of fetuses in cephalic presentation at term |
Secondary outcomes | The percentage of cephalic presentation 2Â weeks later, 4Â weeks later, 6Â weeks later, and at delivery, the rate of cesarean delivery, the rate of cesarean delivery for breech presentation, recurrent breech presentation after cephalic version, and adverse effects |