Induction of Labor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Christian Medical College and Hospital, Ludhiana, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Single center interventional single-blinded randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interval between induction and delivery | From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days | The time taken from induction of labor to delivery measured as 1\) \<12 hours 2) 12-24 hours 3) 24-48 hours 4) \>48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of misoprostol doses | From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days | Measured as 1-2; 3-4; 5-6; 7-8; \>9 |
| Time taken to give required doses | From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days | Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours |
| Total misoprostol dosage | From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days | Measured as \</=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; \>301 mcg |
| Mode of delivery | Upto 5 days from first dose of oral misoprostol solution | In terms of Vaginal delivery/LSCS |
| Mean change in modified Bishop's score | From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days | Measured as difference between modified bishop's score before induction of labor and at amniotomy/stopping of oral misoprostol solution regimen; minimum 0f 1 to maximum of 7. |
| Oxytocin augmentation | From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days | Required/Not required |
| Maternal morbidity | From first dose of oral misoprostol solution to dischage from hospital; upto 7 days | In terms of incidence of either of the following: 1. Incidence of tachysystole 2. Fever- intrapartum and postpartum 3. Puerperal sepsis 4. Uterine rupture |
| Neonatal parameters | From childbirth to discharge of the baby; upto 1 month | Measured in terms of incidence of either of the following: 1. Incidence of meconium-stained liquor 2. APGAR scores at 1,5 min 3. NICU stay |
| Indication for LSCS | Upto 5 days from first dose of oral misoprostol solution | Divided into either of the following: 1. SECONDARY ARREST OF DILATATION 2. MSAF IN EARLY LABOR 3. CTG CATEGORY III 4. FAILED INDUCTION 5. CEPHALOPELVIC DISPROPORTION 6. CORD PROLAPSE 7. DEEP TRANSVERSE ARREST 8. ARREST OF DESCENT OF HEAD |
Countries
India
Outcome results
None listed