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

Post-term Pregnancy (40 to 42 Weeks Gestation) Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392988
• Other study ID #: 0002-15
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 18, 2015
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2015
• Source: Meir Medical Center
• Contact: Liat Edry, PhD
• Phone: 0508520296
• Email: liatedry[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-term Pregnancy (40 to 42 Weeks Gestation)
• Pregnancy, Prolonged

Intervention

Other:
• acupuncture treatment
acupuncture treatment
• Placebo Comparator
Placebo Comparator

Locations

Country	Name	City	State
Israel	Meir Medial Center	Kfar Saba

Sponsors (3)

Lead Sponsor	Collaborator
Meir Medical Center	Clalit Health Services, Reidman college

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of women who received birth induction after week 41		three weeks	No
Secondary	Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).		three weeks	No
Secondary	Duration of labour		three weeks	No
Secondary	Time past from treatment (acupuncture vs. placebo) till labour		three weeks	No
Secondary	Hg before and after labour		three weeks	No
Secondary	Number of women who received epidural		three weeks	No
Secondary	Type of labour		three weeks	No
Secondary	Apgar score after birth		three weeks	No