The adjunctive effect of a qigong (Baduanjin) intervention program on maternal and child health outcomes: a multicenter randomized controlled trial protocol.

INTRODUCTION

Lifestyle interventions are critical for optimizing maternal and child health outcomes during pregnancy. As a mind-body exercise rooted in the principles of traditional Chinese Medicine (TCM), qigong shows promise as adaptable prenatal interventions, but the evidence is limited.

OBJECTIVE

This multicenter randomized controlled trial (RCT) protocol aims to evaluate the additive effect of a qigong intervention program, compared to routine lifestyle intervention alone, on reducing the rate of caesarean section (primary outcome) and improving a range of secondary maternal and child health outcomes.

METHODS

This multicenter RCT will be conducted across 11 institutions in China. A total of 1062 participants aged 18-45 years, with singleton pregnancies at 11-13+ 6 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomization method. Participants will be randomized to either a control group receiving standard prenatal care plus evidence-based lifestyle education (encompassing nutrition, physical activity, sleep hygiene, stress management, and environmental avoidance), or an intervention group receiving all control components supplemented with supervised pregnancy-adapted qigong intervention (a modified seated Baduanjin exercise program). The primary outcome is caesarean section rate. Secondary outcomes include obstetric complications (abortion, preterm birth, gestational diabetes mellitus, gestational hypertension, postpartum hemorrhage, fetal growth restriction), neonatal indicators (birth weight, Apgar scores), maternal gestational weight gain, and mental health and sleep-related outcomes assessed through validated instruments such as Perceived Stress Scale-4 (PSS-4) for stress levels, Fear of Birth Scale (FOBS) for fear of childbirth, and Brief Pittsburgh Sleep Quality Index (B-PSQI) for sleep quality.

CONCLUSION

This rigorously designed multicenter RCT protocol addresses a significant gap by investigating whether integrating the traditional mind-body practice of qigong into standard prenatal lifestyle education confers additional benefits for reducing cesarean sections and enhancing broader maternal-child health metrics. The findings will provide robust evidence on the clinical value of this TCM intervention in integrative prenatal care to improve pregnancy outcomes and maternal and child well-being.

TRIAL REGISTRATION: This trial was registered at International Traditional Medicine Clinical Trial Registry, ITMCTR2025002612.