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Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)

Primary Purpose

Post-term Pregnancy (40 to 42 Weeks Gestation)

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture treatment
Placebo Comparator
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-term Pregnancy (40 to 42 Weeks Gestation)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women past their due date (week 40)
  2. Proper dating of pregnancy
  3. Uncomplicated pregnancy
  4. Normal evaluation as part of the mother and fetus routine examination on week 40
  5. Singleton pregnancy
  6. No contraindication for vaginal birth
  7. No significant signs of birth

Exclusion Criteria:

  1. Past Cesarean Section
  2. Women who have undergone acupuncture treatment during pregnancy
  3. Women who did not undergo separation membranes

Sites / Locations

  • Meir Medial Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Group receives sham treatment

Group receives acupuncture treatment

Group doesn't receive any treatment

Arm Description

Sham treatment will be given on points on the back, points that are not acupuncture points, so that the patient will not be able to know whether she is receiving sham treatment or a real treatment. The treatment will be every 48-72 hours, a maximum of three treatments.

The women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments.

The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop.

Outcomes

Primary Outcome Measures

The number of women who received birth induction after week 41

Secondary Outcome Measures

Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
Duration of labour
Time past from treatment (acupuncture vs. placebo) till labour
Hg before and after labour
Number of women who received epidural
Type of labour
Apgar score after birth

Full Information

First Posted
March 2, 2015
Last Updated
March 18, 2015
Sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Reidman college
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1. Study Identification

Unique Protocol Identification Number
NCT02392988
Brief Title
Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)
Official Title
Randomised ,Single Blind, Placebo Controlled in Meir Medical Center. Study the Potential of Acupuncture Therapy to Reduce the Need for Labor Induction After Postdate (Week 41)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Reidman college

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In recent years, it is accepted to induce birth at week 41 in order to reduce the risk in surplus pregnancies. It was found that after 41 weeks, there is a significant increase in pregnancy complications including meconium liquor, shoulder dystocia and fetal death in uterus. Induction at 41 weeks was found to reduce the risk of complications described above, without taking the risk of cesarean section and, therefore, the recommendation of the Israel Society of Maternal Fetal Medicine, is to induce birth for women who completed 41 weeks of pregnancy. Induction is performed mechanically by entering a balloon to the cervix or by medicated prostaglandins and later, intravenous Pitocin to most women. The process takes two to three days with about 60-70% success rate. In recent years there has been a growing awareness to use natural methods to start labor. Many women tend to turn to natural medicine in order to reduce the need for conventional drugs to start labor. Given the lack of research on the issue and considering the rising demand of the involvement of alternative medicine in labor induction process, the investigators decided to carry out research on this subject.
Detailed Description
To the study will be recruited women who have completed 40 weeks of pregnancy and have not yet given birth, with proper evaluation of mother and fetus. Women who are fit to participate and had given their consent, will be computerized randomized to one of three groups. Research groups: Group who receives acupuncture treatment in order to accelerate the development of birth. Group who receives sham treatment - non acupuncture treatment, but a similar treatment, so that the patient is unable to know whether she is receiving a real acupuncture treatment, or the similar one, which has no effect on the patient. Group who does not receive any treatment and will be reviewed a week later, unless a spontaneous birth will be developed. (Procedure accepted today) The study will be carried out between week 40 and week 41. During the week acupuncture treatment, sham treatment or conservative follow-up will be carried out, depending on the study group differentiation. All women who will be randomized to the treatment groups, will fill a preliminary questionnaire for acupuncture treatment. The course of treatment: During the week of study the women in the treatments groups will receive treatment every 48-72 hours, a maximum of three treatments. Measures will be taken on the following week or two when the women will come to give birth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-term Pregnancy (40 to 42 Weeks Gestation)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group receives sham treatment
Arm Type
Placebo Comparator
Arm Description
Sham treatment will be given on points on the back, points that are not acupuncture points, so that the patient will not be able to know whether she is receiving sham treatment or a real treatment. The treatment will be every 48-72 hours, a maximum of three treatments.
Arm Title
Group receives acupuncture treatment
Arm Type
Experimental
Arm Description
The women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments.
Arm Title
Group doesn't receive any treatment
Arm Type
No Intervention
Arm Description
The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop.
Intervention Type
Other
Intervention Name(s)
acupuncture treatment
Intervention Description
acupuncture treatment
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
The number of women who received birth induction after week 41
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
Time Frame
three weeks
Title
Duration of labour
Time Frame
three weeks
Title
Time past from treatment (acupuncture vs. placebo) till labour
Time Frame
three weeks
Title
Hg before and after labour
Time Frame
three weeks
Title
Number of women who received epidural
Time Frame
three weeks
Title
Type of labour
Time Frame
three weeks
Title
Apgar score after birth
Time Frame
three weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women past their due date (week 40) Proper dating of pregnancy Uncomplicated pregnancy Normal evaluation as part of the mother and fetus routine examination on week 40 Singleton pregnancy No contraindication for vaginal birth No significant signs of birth Exclusion Criteria: Past Cesarean Section Women who have undergone acupuncture treatment during pregnancy Women who did not undergo separation membranes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liat Edry, PhD
Phone
0508520296
Email
liatedry@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Biron-Shental, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medial Center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

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Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)

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