Induction of Labour Clinical Trial
Official title:
A Randomized Controlled Trial of Oral Misoprostol, Low Dose Vaginal Misoprostol and Vaginal Dinoprostone for Induction of Labour
Verified date | April 2018 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Labour induction is a frequent obstetric intervention (~20%). Prostaglandins (PGs) are effective agents, but gastrointestinal (GI) intolerance has limited use to non-oral routes. The traditional oxytocin "drip" requires intravenous (IV) use and discourages mobility. Misoprostol, a PG analogue, is marketed for oral treatment of GI disorders, but initiates uterine contraction, an undesirable GI side effect. Recently, there has been a research "boom" on vaginal misoprostol use in pregnancy to induce term labour drawing on this "side effect:". The principal investigator has led one of three groups worldwide which has published on oral misoprostol to study effectiveness, GI tolerance, and safety for mother/baby in term labour induction. Cost per patient has been less then one percent that of other PGs, even less than IV oxytocin.
Status | Completed |
Enrollment | 511 |
Est. completion date | December 1, 2000 |
Est. primary completion date | December 1, 2000 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - pregnant women - gestational age 37 weeks or more based on ultrasound before 24 weeks - live single fetus in cephalic presentation - indication for induction of labour Exclusion Criteria: - non reassuring fetal heart rate tracing - maternal prior uterine surgery - known hypersensitivity to misoprostol or other prostaglandin - contraindication to vaginal birth - fetal anomaly identified on antenatal ultrasound - uncontrolled maternal asthma or epilepsy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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David Young |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vaginal birth in less than 24 hours | Frequency of newborns with vaginal birth in less than 24 hours from randomization (induction). | Randomization to newborn birth, assessed through to study completion, up to 10 weeks | |
Other | Time interval from randomization to full dilation | ANOVA analysis for mothers with vaginal birth | Randomization to newborn birth, assessed through to study completion, up to 10 weeks | |
Other | First stage of labor duration | ANOVA analysis of time interval from labor onset to full dilation for mothers with vaginal birth | Randomization to newborn birth, assessed through to study completion, up to 10 weeks | |
Other | Second stage of labor duration | ANOVA analysis of time interval from full dilation to vaginal birth for mothers with vaginal birth | Randomization to newborn birth, assessed through to study completion, up to 10 weeks | |
Other | Maternal satisfaction questionaire | ANOVA analysis of participants' total score on the Labour Agentry Scale(LAS). The LAS will be given to consenting participants as a written questionnaire prior to maternal discharge. A mother will be asked to try to remember how she felt during her recent birth experience. If a response is not received by eight weeks following maternal discharge a single reminder telephone contact will made. The LAS is a seven point Likert scale. It measures a mother's sense of control during labor. Score range is from one to seven on each of 18 items. The minimum score is 18 and maximum score is 126. A higher score indicates a greater sense of control. (Hodnett ED, Simmons-Tropea DA. The Labour Agentry Scale: Psychometric properties of an instrument measuring control during childbirth. Res Nurs Health 1987;10:301-10) | Randomization to maternal hospital discharge, assessed up to 10 weeks | |
Other | Maternal satisfaction choice | Frequency of response (yes/no) by participants to written question "If you needed a labor induction in another pregnancy would you want to have the same induction method ?" This question was administered with the questionnaire in Outcome 21 above, given to mother prior to hospital discharge. | Randomization to maternal hospital discharge, assessed up to 10 weeks | |
Primary | Time interval from induction (at randomization) to vaginal birth | The chosen clinically important difference: 4 hours (240 minutes) difference. Caesarean sections could not be included in this planned parametric analysis (ANOVA) comparison of means | Randomization to newborn vaginal birth, assessed through to study completion, up to 10 weeks | |
Secondary | Time interval from induction (at randomization) to birth | Rank order nonparametric analysis [Kruskal Wallis (KW)] where a Caesarean is a failure to deliver vaginally and ranked longer than any vaginal birth- comparison of medians (KW ANOVA). | Randomization to newborn birth, assessed through to study completion, up to 10 weeks | |
Secondary | Profound newborn acidemia | Frequency of newborns with umbilical cord blood arterial pH < 7.0 | Cord blood gas sample collected at birth | |
Secondary | Newborn respiratory depression | Frequency of newborns with Apgar score at 5 minutes < 4 | Assessed at 5 minutes after birth | |
Secondary | Newborn birth asphyxia | Frequency of participants whose newborn experiences birth asphyxia as defined in the American College of Obstetrics and Gynecology Committee Opinion # 197 (Int J Gynecol Obstet 1998;61:309-10). The newborn with birth asphyxia must have each of the following four criteria :[1] profound academia (umbilical cord blood arterial pH< 7.0, obtained at birth); and (2) Apgar score <4 at five minutes as assessed by neonatal caregivers; and [3] neonatal neurologic sequelae (newborn with one or more of seizures, hypotonia, coma);and [4] dysfunction in one or more of the cardiovascular, gastrointestinal, hematologic, pulmonary, hepatic or renal systems. Criteria (3) and (4) are as assessed by neonatal caregivers from birth to newborn hospital discharge. | Birth to newborn hospital discharge, assessed up to 10 weeks | |
Secondary | Newborn severe metabolic acidemia | Frequency of newborns with umbilical cord arterial blood base deficit >16.0 mmol/L | Cord blood gas sample collected at birth | |
Secondary | Newborn moderate metabolic acidemia | Frequency of newborns with umbilical cord arterial blood base deficit >12.0 mmol/L | Cord blood gas sample collected at birth | |
Secondary | Birth method | Frequency of spontaneous, operative vaginal (vacuum and/or forceps), or caesarean birth | At newborn birth | |
Secondary | Oxytocin Use | Frequency of participants who received intrapartum use of oxytocin for labor augmentation or induction | Randomization to maternal delivery, assessed through to study completion, up to 10 weeks | |
Secondary | Epidural Use | Frequency of participants who received an epidural for intrapartum analgesia | Randomization to maternal delivery, assessed through to study completion, up to 10 weeks | |
Secondary | Perineal Trauma | Frequency of participants who had received suture perineal repair of a laceration or episiotomy | Randomization to maternal hospital discharge, assessed up to 10 weeks | |
Secondary | Caesarean Section | Frequency of Caesarean section | At newborn birth | |
Secondary | Maternal nausea | Frequency of participants who had nausea during labor | Randomization to maternal delivery, assessed through to study completion, up to 10 weeks | |
Secondary | Maternal vomiting | Frequency of participants who had vomiting during labor | Randomization to maternal delivery, assessed through to study completion, up to 10 weeks | |
Secondary | Maternal diarrhea | Frequency of participants experiencing diarrhea during labor | Randomization to maternal delivery, assessed through to study completion, up to 10 weeks | |
Secondary | Excessive uterine activity | Frequency of tachysystole and/or hyperstimulation - blind review of fetal heart rate, uterine contraction tracings by research team physician, remote from delivery. | Randomization to birth, assessed through to study completion, up to 10 weeks |
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