A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- prevention of inpatient induction of labor
Study Overview
Brief Summary
The purpose of this study is to assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy.
Detailed Description
There are certain medical conditions that can complicate pregnancies after 40 weeks gestation. However, it is not always safe or easy to put these women into labor. Acupuncture has been used in Asia for hundreds of years to induce contractions and begin the labor process. Acupuncture is not typically used in the United States to induce labor, however. The purpose of this study is to determine whether a series of up to five acupuncture treatments can prevent postdates pregnancy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •first, full-term pregnancy
- •38-41 weeks gestation
- •English or Spanish speaking
- •Bishop score of 7 or less
Exclusion Criteria
- •uncertain pregnancy dating
- •transportation difficulties
- •previous inability to tolerate acupuncture
- •age less than 18
Arms & Interventions
Acupuncture
Intervention: Acupuncture (Procedure)
Sham Acupuncture
Intervention: Sham comparator (Procedure)
Usual care only
Outcomes
Primary Outcomes
prevention of inpatient induction of labor
Secondary Outcomes
- length of maternal hospital stay
- rates of assisted delivery
- rate of cesarean delivery
- rates of chorioamnionitis
- neonatal outcomes