Delivery, Obstetric Clinical Trial
Official title:
Acupuncture for Promotion of Timely Delivery
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.
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".
;
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