Induction of Labor by Oral Misoprostol Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-11-30

Brief Summary

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AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with static-dose oral misoprostol solution for induction of labor at term.

Women with singleton live pregnancy at term without any complications who were admitted in labor room for induction of labor were enrolled.

Study involves allocation of selected women in two groups randomly and use of either titrated or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid induction of labor with oral drug regimen which is easier to comply as compared to vaginal regimens. Women were at risk of all the complications associated with induction of labor like labor abnormalities, risk of cesarean section, non reassuring fetal status.

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Detailed Description

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This comparative randomized study was conducted in the Department of Obstetrics and Gynecology, Christian medical college and hospital, Ludhiana for a period of one year beginning from 1st December, 2017 to 30th November, 2018. The study group comprised of all antenatal women admitted in labor room at term for induction of labor. Informed consent was taken for all selected women. Women were subjected to detailed history taking, a complete physical examination including per vaginum examination (to calculate modified bishop's score and to rule out cephalopelvic disproportion), investigations and a NST. Gestational age was established by the first date of the last menstrual period and confirmed by first trimester ultrasound. Presentation was confirmed by palpation and third trimester ultrasound.

Women after randomization were allocated into two groups. The first group (A) was induced with hourly titrated oral misoprostol regimen and the second group (B) received two hourly static oral misoprostol regimen. Once labor had started, vital signs were closely monitored every 2 hours; fetal heart rate (FHR) and uterine activity every 15 minutes during first stage of labor. Per vaginum examination was done 4-hourly or as indicated.

Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy of titrated and oral misoprstol solution.

Conditions

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center interventional single-blinded randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence. Allocation concealment was carried out by using opaque envelopes that were distributed by the obstetrics nurse. Whereas study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures like timing of oral misoprostol solution doses.

Study Groups

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Group A (Titrated OMS)

Titrated oral misoprostol solution

Group Type ACTIVE_COMPARATOR

Oral misoprostol solution (OMS)

Intervention Type DRUG

Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.

Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.

0 hour= 20ml

1. hour= 20ml
2. hour= 30ml
3. hour= 30ml
4. hour= 30ml
5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml

Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

Group B (Static OMS)

Static oral misoprostol solution

Group Type ACTIVE_COMPARATOR

Oral misoprostol solution (OMS)

Intervention Type DRUG

Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.

Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.

0 hour= 20ml

1. hour= 20ml
2. hour= 30ml
3. hour= 30ml
4. hour= 30ml
5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml

Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

Interventions

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Oral misoprostol solution (OMS)

Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.

Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.

0 hour= 20ml

1. hour= 20ml
2. hour= 30ml
3. hour= 30ml
4. hour= 30ml
5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml

Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Singleton live pregnancy;
2. ≥37 weeks gestation;
3. Cephalic presentation;
4. Reassuring fetal heart rate;
5. Modified Bishop'score

Exclusion Criteria

1. Hypersensitivity to misoprostol;
2. Uterine scar due to previous cesarean section or other uterine surgery;
3. Grand multipara;
4. Multiple gestations;
5. High risk pregnanacies • preeeclampsia with severe features • significant maternal cardiac,renal, liver disease
6. Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage
7. Intrauterine fetal demise

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes