Cervical Dystocia Clinical Trial
Official title:
A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy
The principal objective of the trial is to demonstrate that acupuncture could reduce the
caesarean section rate for cervical dystocia.
Secondary objectives:
To demonstrate that acupuncture can:
- reduce morbidity, fetal mortality and duration of childbirth;
- reduce the cost of care, due to diminution of caesarean sections and duration of
obstetric labor;
- to evaluate the tolerance.
In this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to
traditional chinese acupuncture, sham acupuncture, or usual care only.
9 investigator sites will participate to this trial targeting to enrol 2220 patients in
total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham,
whereas 400 patients will receive usual care only.
Acupuncture therapy consists in stimulations on specific skin points of the abdominal area,
which are specific acupuncture points in traditional chinese medicine for the induction of
obstetric labor, according to the professional recommendations of the French Acupuncture and
Traditional Chinese Medicine College.
Each patient will have a 5-week follow-up in this trial.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02694315 -
Cervical Length and Bishop Score in Preinduction Cervical Assessment Prior to Induction of Labor
|
N/A | |
| Completed |
NCT03430804 -
Transvaginal Sonographic Measurement of Cervical Length Versus Bishop Score in Induction of Labour for Prediction of Caesarean Delivery.
|
N/A |