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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Post-term Pregnancy (40 to 42 Weeks Gestation)
• Intervention / Treatment: Other: Placebo Comparator; Other: acupuncture treatment

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:

1. Group who receives acupuncture treatment in order to accelerate the development of birth.
2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group receives sham treatment; 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.	Other: Placebo Comparator; Placebo Comparator
EXPERIMENTAL: Group receives acupuncture treatment; The women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments.	Other: acupuncture treatment; acupuncture treatment
NO_INTERVENTION: Group doesn't receive any treatment; The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of women who received birth induction after week 41	three weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Clalit Health Services; Reidman college

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ANTICIPATED): May 1, 2017
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (ESTIMATE): March 19, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pregnancy, Prolonged
• Other Study ID Numbers: 0002-15