Acupuncture for Promotion of Timely Delivery
Condition: Delivery, Obstetric
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study of 100 pregnant women is to determine if acupuncture using real
      needles that puncture the skin, starting at thirty seven weeks three days estimated
      gestational age (EGA), will increase the percentage of women delivering on or before the
      estimated date of confinement (EDC = 40 weeks EGA), compared with women treated identically
      but with placebo needles that do not puncture the skin.
    

Detailed description: 
      General Design This is a randomized controlled study of pregnant women to determine if
      acupuncture starting at thirty seven weeks three days EGA will increase the percentage of
      women delivering on or before the EDC, 40 weeks EGA.

      The study participants will be recruited at three practices which utilize St. Francis
      Hospital in Wilmington Delaware, practices and hospital well known to the primary
      investigator. With the permission of the patients' physicians, charts of potentially eligible
      patients will be reviewed and eligible patients will be recruited into the study prior to 36
      weeks EGA.

      Upon enrollment, patients will be separated into nulliparous and parous groups and each group
      will be randomized into study intervention or control groups.

      Of note, the candidate population is comprised of English and Spanish speakers. All
      invitational, explanatory, and consent materials and study instruments are available in both
      English and Spanish.

      In addition to demographic information, initial and periodic "quality of life" and anxiety
      inventories will be administered. Based upon the current literature for applicability in this
      particular study population, the State-Trait Anxiety Index (STAI) and the Short Form 36
      (SF-36) have been chosen as the test instruments.

      Both primary care providers and enrolled patients will be asked every week to answer a single
      question with regards to whether or not they think the patient is receiving true or placebo
      acupuncture treatments. This will be done to analyze the efficacy of the blinding process.

      At the time of enrollment, each patient will have a cervical exam performed by their
      physician to determine their individual baseline Bishop's Score. Subsequently, at each weekly
      obstetrical visit up to the patient's EDC, another cervical examination will be performed and
      a Bishop's Score obtained to assess cervical ripening.

      Each subject will be seen twice weekly by the acupuncturist and will receive either actual
      acupuncture treatment or placebo (non-puncturing needles) treatment. Patients identified as
      "high risk" based upon the clinical judgment of the primary care physician will have external
      uterine pressure monitoring and fetal heart rate monitoring during the acupuncture
      treatments.

      The acupuncture treatments will be administered in a standardized way by a single experienced
      medical acupuncturist certified by the state of Pennsylvania, to reduce the variability in
      the study. The acupuncture will be performed in a quiet area for all subjects. The newly
      validated and now commercially available placebo needle developed by Streitberger, et al will
      be used 34 and identical real needle using the same procedure for the placement of both types
      of needles. Briefly, a small bandage is applied to the skin covering a thin plastic disk over
      each acupuncture site. Either needle is placed through one of the small hole in the plastic
      portion of the bandage and through the underlying gauze. The sharp real needle easily
      penetrates the skin to the required depth, with no resistance imposed by the bandage. The
      blunt shaft of the placebo needle applies pressure on the skin as it retracts into the hollow
      handle, giving the appearance of the needle going into the skin. The bandage and gauze hold
      the placebo needle in place. The acupuncture needles will be manipulated for a few seconds on
      at the beginning and in the middle of the 30 minutes treatment period to try to elicit a
      sensation called the De qi. It is sometimes perceived by the subject as a dull ache that
      radiates from the point of insertion, or can be detected by the acupuncturist as a sense of
      increased resistance.

      Since both the real and placebo needle groups reported feeling some sensation in
      Streitberger's validation study and the published study 35 blinding of the subject will be
      preserved. To ensure that the blinding is adequate, at each prenatal visit and at the
      postpartum follow up visit a simple question will be asked of study subjects and of their own
      physicians regarding which type of treatment (real versus placebo acupuncture) they believe
      the subject received in each session.

      Primary Study Endpoints Our goal is to determine if our study intervention, acupuncture, will
      increase by 30% the number of women who have a timely delivery-- deliver on or before the
      EDC. Our study endpoint will be the EGA at the time of delivery. We will answer the question:
      "Was it a timely delivery?"

      Primary Safety Endpoints If during the trial there is any evidence clinically or on monitor
      of uterine over-stimulation or fetal intolerance, the patient will remain enrolled as
      "intention to treat", but not continue with acupuncture treatments.

      If the physician caring for the patient (obstetrician or FP-obstetrician) has any concerns
      that warrant the discontinuation of the acupuncture treatments, the patient will be withdrawn
      from the study and will be followed as "intention to treat".
    

Intervention name(s): Acupuncture; Non-puncturing Acupuncture Needle
Intervention type(s): Procedure; Device
Intervention description(s): Acupuncture administered in last three weeks of pregnancy; Streitsberg non-Acupuncture Needle
Other intervention name(s): Asia Medicine Produces needle; Asia Medicine produces this needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnancy; Acupuncture; Pregnancy Outcome; Randomized Controlled Trial; Double-Blind Method