The Value of Oral Micronized Progesterone in the Prevention of Spontaneous Preterm Birth
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- The rate (incidence) of preterm delivery (gestational age <37 weeks).
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study.
详细描述
Intervention:
The study subjects will be randomized to receive twice daily tablets of either 100 mg of OMP (Uterocare®, October Pharma , Sixth of October city, Egypt) or placebo from enrollment (14-18 weeks) until 36 weeks or delivery, whichever occurs first. The patients and medical staff will be blinded to the study medication allocation.
Method of Randomization:
All patients who are fit for admission into the study will pull one of the numbered sealed identical black bags containing either the active medicine (=25%), the placebo (with the aim of admission into data collection, =25%), or a placebo together with a short note explaining that they will not be admitted to the study (=50%) and that they can give back their bag to the head nurse.
The code for the 424 (106x4) bag numbers is a confidential computer generated random number list (generated using MedCalc© Software bvba, Ostend, Belgium). It will be left, in a sealed envelope, with the head nurse of the antenatal clinic, till the end of data collection.ruptured membranes.
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
- Triple (Participant, Care Provider, Investigator)
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 pregnancies.
- •Gestational age, on admission, is between 14 and 18 weeks.
- •Past history of at least one idiopathic preterm birth.
排除标准
- •Established preterm labor (cervical dilatation ≥ 4 cm).
- •Persistent uterine contractions.
- •Women with medical or surgical complications indicating delivery or termination of pregnancy.
- •Presence of fetal anomalies incompatible with life.
- •Premature rupture of membranes.
研究组 & 干预措施
group A
subjects will recieve twice daily tablets of 100 mg of oral Micronized Progesterone from (14-18 weeks) until 36 weeks or delivery.
Subjects: 106 cases Name: Oral micron ized progesterone Form: oral tablets Dosage: one tablet Frequency: every 12 hours Duration: 14-36 weeks gestational age.
干预措施: micronized progesterone (Drug)
Group B
subjects will receive placebo twice daily from (14-18 weeks) until 36 weeks or delivery.
Subjects: 106 cases Name: placebo Form: oral tablets Dosage: one tablet Frequency: every 12 hours Duration: 14-36 weeks gestational age.
干预措施: Placebo (Drug)
结局指标
主要结局
The rate (incidence) of preterm delivery (gestational age <37 weeks).
时间窗: up to 37weeks.
Patients will be followed up regularly, at twice monthly intervals, in the antenatal clinic of Ain Shams University Maternity Hospital until delivery. They will be instructed to return to the hospital when recurrence of symptoms of preterm labor, rupture of membranes, or vaginal bleeding. There will be telephone call follow up routinely to ensure adherence to the study protocol.
次要结局
- The neonatal birth weight(up to 37 weeks.)
- The incidence of rupture of the amniotic membranes.(up to 37weeks.)
研究者
Ahmed Adel Abdel-Aziz
Registrar of OB/GYN
Ghamra Military Hospital