Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379327
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2006-09-19
Brief Title:
Acupuncture for Promotion of Timely Delivery
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Acupuncture for Promotion of Timely Delivery
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Bishops Score Subsequently at each weekly obstetrical visit up to the patients EDC another cervical examination will be performed and a Bishops 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 Streitbergers 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
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 Bishops Score Subsequently at each weekly obstetrical visit up to the patients EDC another cervical examination will be performed and a Bishops 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 Streitbergers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None