Post-term Pregnancy (40 to 42 Weeks Gestation)NCT02392988
Does Acupuncture Therapy Reduce the Need for Labor Induction After Postdate (Week 41)
A study testing acupuncture treatment in people with Post-term Pregnancy (40 to 42 Weeks Gestation), run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-term Pregnancy (40 to 42 Weeks Gestation)
- What is being tested?
- acupuncture treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Past Cesarean Section
- Women who have undergone acupuncture treatment during pregnancy
- Women who did not undergo separation membranes
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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.
- Being tested
- acupuncture treatment, Placebo Comparator
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture treatmentOther
acupuncture treatment
Placebo ComparatorOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Group receives sham treatment | Placebo comparator | 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. Receives: Other: Placebo Comparator |
| Group receives acupuncture treatment | Experimental | The women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments. Receives: Other: acupuncture treatment |
| Group doesn't receive any treatment | No intervention | The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who received birth induction after week 41
Measured: three weeks
Secondary outcomes (7)
Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
Measured: three weeks
Duration of labour
Measured: three weeks
Time past from treatment (acupuncture vs. placebo) till labour
Measured: three weeks
Hg before and after labour
Measured: three weeks
Number of women who received epidural
Measured: three weeks
Type of labour
Measured: three weeks
Apgar score after birth
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-term Pregnancy (40 to 42 Weeks Gestation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Reidman college
- Responsible party
- Sponsor
- Investigators
- Tal Biron-Shental, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392988
- Sponsor's protocol ID
- 0002-15
- Status last verified
- Feb 2015
- First submitted
- 2 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02392988
- Acronym / sponsor ID
- 0002-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Reidman college
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group receives sham treatment | Placebo comparator | Other: Placebo ComparatorSham 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 receives acupuncture treatment | Experimental | Other: acupuncture treatmentThe women in this group will receive acupuncture treatment every 48-72 hours, a maximum of three treatments. |
| Group doesn't receive any treatment | No intervention | –The women in this group will come for a follow-up check a week later, unless a spontaneous birth will develop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Past Cesarean Section
- Women who have undergone acupuncture treatment during pregnancy
- Women who did not undergo separation membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture treatmentacupuncture treatment | Other | Group receives acupuncture treatment |
| Placebo ComparatorPlacebo Comparator | Other | Group receives sham treatment |
Primary outcome
The number of women who received birth induction after week 41
Time frame: three weeks
7 secondary outcomes
Number of women who had SROM (spontaneous rupture of membranes) or AROM (artificial rupture of membranes).
Time frame: three weeks
Duration of labour
Time frame: three weeks
Time past from treatment (acupuncture vs. placebo) till labour
Time frame: three weeks
Hg before and after labour
Time frame: three weeks
Number of women who received epidural
Time frame: three weeks
Type of labour
Time frame: three weeks
Apgar score after birth
Time frame: three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tal Biron-Shental, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture treatment in people with Post-term Pregnancy (40 to 42 Weeks Gestation), run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liat Edry, PhD (0508520296, liatedry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who received birth induction after week 41 (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.