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

NCT ID: NCT02392988

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-05-31

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:

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.

Conditions

Post-term Pregnancy (40 to 42 Weeks Gestation)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: OTHER

Placebo Comparator

Group receives acupuncture treatment

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

Group Type: EXPERIMENTAL

acupuncture treatment

Intervention Type: OTHER

acupuncture treatment

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture treatment

acupuncture treatment

Intervention Type: OTHER

Placebo Comparator

Placebo Comparator

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clalit Health Services

OTHER

Sponsor Role: collaborator

Reidman college

UNKNOWN

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tal Biron-Shental, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medial Center

Kfar Saba, , Israel

Countries

Israel

Central Contacts

Liat Edry, PhD

Role: CONTACT

liatedry@gmail.com

0508520296

Other Identifiers

0002-15

Identifier Type: -

Identifier Source: org_study_id