Clinical trial NCT02392988: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-term Pregnancy (40 to 42 Weeks Gestation)
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
name: Reidman college
First posted: 2015-03-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The number of women who received birth induction after week 41
timeFrame: three weeks
Secondary outcomes:
measure: Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
timeFrame: three weeks
measure: Duration of labour
timeFrame: three weeks
measure: Time past from treatment (acupuncture vs. placebo) till labour
timeFrame: three weeks
measure: Hg before and after labour
timeFrame: three weeks
measure: Number of women who received epidural
timeFrame: three weeks
measure: Type of labour
timeFrame: three weeks
measure: Apgar score after birth
timeFrame: three weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medial Center
Study officials:
affiliation: Meir Medical Center
name: Tal Biron-Shental, MD
role: PRINCIPAL_INVESTIGATOR
References: