Outpatient Cervical Ripening and Labor Induction With Orally Administered Misoprostol for Term Pregnancies Complicated by Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure Will be the Time Interval From Start of Induction to Delivery.
研究概览
简要总结
A. Null Hypothesis:
In term pregnancies complicated by diabetes, there is no difference in the time interval from start of induction to delivery when outpatient cervical ripening and labor induction is initiated with orally administered misoprostol, a prostaglandin El analogue, compared to placebo.
B. Specific aims:
- Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus.
- Demonstrate that oral misoprostol can be administered safely in an outpatient setting. The patients will be observed for a period of four hours in an outpatient antepartum testing unit after the medication is administered to demonstrate fetal well being and verify that there is no evidence of uterine hyperstimulation. (We acknowledge that markers of serious adverse maternal and neonatal outcomes are rare, and can only be adequately addressed in large multicenter trials.)
- Assess the cost differential in inpatient and outpatient utilization of misoprostol for cervical ripening and labor induction. In order to estimate the impact that outpatient cervical ripening may have on total hospitalization costs, we will use daily hospital charges and published data regarding pharmaceutical costs.
详细描述
The study proposed is a single center study. Study participants will be recruited from the high risk obstetrical diabetic resident clinic, the Magella Women's Perinatal Group, and Fetal Diagnostics at Miller Children's hospital. The resident clinic is supervised by the faculty from the division of Maternal Fetal Medicine from the department of Obstetrics and Gynecology. Patients with class A1, A2 diabetes mellitus at term who are usually considered for inpatient cervical ripening and labor induction will be approached for participation in the study. Informed consent will be obtained by members of the perinatal research team.
One hundred twenty-eight patients will be enrolled to assess treatment efficacy. Sixty four patients will be treated with misoprostol 50mcg PO q day for two days (days 1 and 4) and sixty four patients will receive placebo (vitamin C) q day for two days (days 1 and 4) for cervical ripening and labor induction.
Sample size calculations were performed assuming that 50% of untreated patients will deliver within 7 days of entry. Using an estimate that a 50% increase in this number to 75% would be clinically important, and assuming a Type I error of 0.05 and a Type II error of 0.2, we calculated that a sample size of 58 patients in each group was necessary. The test was one-sided. Assuming a 10% loss to follow-up rate, sixty four patients will be needed in each group.
A predetermined randomization schedule for the 128 patients has been established and the randomization assignments placed in opaque, sealed envelopes. The randomization was performed using a computer-generated random number table. The pharmacy will prepare and distribute the study medication according to the randomization schedule after eligible participants sign the informed consent. Once a patient is randomized, the pharmacy will be contacted to provide the medications to the research/antepartum testing unit nurse.
The proposed study length is two years, or the time needed to enroll 128 total participants. Each individual's total participation time is that needed to complete the protocol. After delivery, the prenatal and hospital charts of each participant will be reviewed and data abstracted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation
- •Intact membranes
- •Bishop score <= 4
- •Uterine contractions <=12/hour
- •Cephalic presentation
- •Estimated gestational age of at least 38 weeks by ACOG dates
- •An amniotic fluid index (AFI) >5 cm
- •Reactive Non Stress Test
- •Class A1, A2 diabetes
- •Good compliance with clinic visits and home glucose monitoring
排除标准
- •I. Fetal Factors
- •Multiple Gestation
- •Presence of fetal distress/non-reassuring FHR pattern
- •Malpresentation, including breech
- •EFW > 4500 gm or other evidence of cephalo-pelvic disproportion
- •EFW < 2000 gm
- •II. Maternal Factors
- •Frequent uterine contractions >= 12/hour
- •Ruptured membranes
- •Placenta previa or unexplained vaginal bleeding
- •Vasa previa
- •Active herpes simplex
- •Glaucoma or elevated intraocular pressure
- •Renal or hepatic dysfunction
- •Previous Cesarean delivery or history of uterine surgery
- •Evidence of chorioamnionitis or maternal fetal >= 100.4 degrees F
- •Significant cardiac lesion or cardiovascular disease
- •Severe asthma
- •Parity >=6
研究组 & 干预措施
1
patients will be treated with misoprostol 50 mcg PO
干预措施: Misoprostol (Drug)
2
patients will receive placebo (Vitamin C)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The Primary Outcome Measure Will be the Time Interval From Start of Induction to Delivery.
时间窗: induction to delivery
Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus. The study was terminated, and no study data and/or analyzed. No study data are available.
次要结局
- Other Outcome Measures Will be Number of Doses of Medication Required, Oxytocin Requirements, and Route of Delivery.(induction to delivery)
- Demonstrate That Oral Misoprostol Can be Administered Safely in an Outpatient Setting.(The PI has left the institution. Efforts were exhausted in attempting to contact the PI/study team members. No study data are available.)