Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Gestational age in weeks at delivery.
研究概览
简要总结
Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life..
There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women
详细描述
This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.
All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.
The study population will be randomly distributed according to the mode of intervention into 3 groups.
Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained
Group 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
- •Presence of risk factor for preterm labor:
- •Previous spontaneous preterm labor in previous singleton Pregnancy, OR
- •Previous spontaneous second trimestric miscarriage less than 3 times, OR
- •Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.
排除标准
- •Multiple pregnancy.
- •Medical or obstetric conditions requiring termination of pregnancy
- •Contraindication to progesterone administration or its use earlier in this pregnancy
- •Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
- •Liver dysfunction or disease.
- •Known or suspected malignancy of breast or genital organs.
- •Undiagnosed vaginal bleeding.
- •Missed abortion.
- •Known sensitivity to progesterone injection.
- •Known sensitivity to sesame oil/seeds.
- •Congenital fetal anomalies
- •Cervical cerclage in the current pregnancy.
- •Presence of uterine anomalies (Unicornuate uterus , Uterus didelphys, bicornuate uterus,Septated uterus) or uterine fibroid.
- •Presence of history of chronic hypertetion, chronic liver or kidney diseases, and pregnancy induced hypertension.
研究组 & 干预措施
17 alpha hydroxyprogestrone caproate Group
Patients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks.
干预措施: 17 alpha hydroxyprogestrone caproate (Drug)
Vaginal progesterone Group
Patients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks.
干预措施: Vaginal progesterone (Drug)
Oral dydrogesterone Group
Patients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks
干预措施: Oral dydrogesterone (Drug)
结局指标
主要结局
Gestational age in weeks at delivery.
时间窗: 6 months
using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery
次要结局
- Neonatal mortality(6 months)
- Unsatisfactory response(6 months)
- Failure of prevention of preterm labor(6 months)
- Birth weight(6 months)
- Hemodynamic changes in fetoplacental circulation(6 months)
- Neonatal APGAR score(6 months)
- Need for NICU admission(6 months)
研究者
mohammed mahmoud samy
Lecturer in Obstetrics and Gynecology
Ain Shams University