Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 8:03 AM
Study NCT ID:
NCT05857059
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration
Sponsor:
Unidade Local de Saúde de Coimbra, EPE
Organization:
Study Overview
Official Title:
Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration - a Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.
Detailed Description:
The prevalence of obesity has increased dramatically in recent decades, with implications for women of reproductive age and changes in obstetric and perinatal outcomes. In Portugal, it is estimated that 38.6 per cent and 13.8 per cent of the population are overweight or obese, respectively. Compared with women of normal weight, obese pregnant women have a higher rate of obstetric complications. These include hypertensive complications, gestational diabetes and fetal macrosomia. These factors lead to an increased need for IOL before the end of the pregnancy and, consequently, to a reduced degree of cervical dilatation prior to IOL. In addition, the above-mentioned co-morbidities are associated with a higher rate of CS. For all these reasons, obese women have higher IOL and CS rates. The literature also confirms that the degree of obesity is directly related to IOL failure. In some studies, the rate of failed induction is 20.2% and 24.2% in women with obesity grades I and II, respectively. However, few studies have been conducted to determine which IOL agents most commonly induce vaginal labour in obese women, and no studies have defined the most appropriate dose for maternal BMI.
This study provides a breakthrough in understanding the mechanism of labour and response to misoprostol in obese women, as there is a lack of prospective human studies in this area.
Sample size calculation was based on CS rate in obese versus non-obese groups as the primary outcome. According to previous studies, a 22% CS rate in non-obese pregnant women undergoing IOL was calculated, with a between-groups difference of 15% on CS rates being considered clinically significant. Therefore, we set the power at 80%, the alpha error at 0.05 and the ratio of the two study groups at 1:1. Accordingly, 114 cases were needed in each group to detect 15% difference in CS rate.
Primary objective: To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL.
Secondary goals: Comparison of successful IOL rates and their relationship with oral misoprostol dose. Evaluation of tolerability and side effects in relation to different doses of oral misoprostol.
This study provides a breakthrough in understanding the mechanism of labour and response to misoprostol in obese women, as there is a lack of prospective human studies in this area.
Sample size calculation was based on CS rate in obese versus non-obese groups as the primary outcome. According to previous studies, a 22% CS rate in non-obese pregnant women undergoing IOL was calculated, with a between-groups difference of 15% on CS rates being considered clinically significant. Therefore, we set the power at 80%, the alpha error at 0.05 and the ratio of the two study groups at 1:1. Accordingly, 114 cases were needed in each group to detect 15% difference in CS rate.
Primary objective: To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL.
Secondary goals: Comparison of successful IOL rates and their relationship with oral misoprostol dose. Evaluation of tolerability and side effects in relation to different doses of oral misoprostol.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: