Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Gestational age at birth
研究概览
简要总结
Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.
Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.
Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.
When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
- •Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
- •Gestational age 23(+0)-32(+6) weeks.
- •Consent to taking part in the study.
排除标准
- •Placenta previa
- •Preterm premature rupture of membranes at presentation
- •Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
- •Known major fetal anomaly detected on ultrasound
- •Multiple pregnancy
- •Maternal seizure disorder
- •Active or history of thromboembolic disease
- •Maternal liver disease
- •Known or suspected breast malignancy or pathology
- •Known or suspected progesterone-dependent neoplasia
- •Plans to move to another city during pregnancy
- •Previous participation in a progesterone trial during this pregnancy
- •Known sensitivity to progesterone
研究组 & 干预措施
Vaginal progesterone
干预措施: Vaginal progesterone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Gestational age at birth
时间窗: At birth
Gestational age at birth calculated from gestational age at pre-randomization baseline
次要结局
- Birth weight (grams)(At time of birth)
- Proportion of women who have preterm birth <35 weeks(At birth)
- Proportion of women who have a preterm birth at <37 weeks(At birth)
- Maternal hospital length of stay (days)(Days from date of admission to date of discharge)
- Neonatal survival to discharge home (yes/no)(During 28 days after birth)
- Number of days of supplemental oxygen (for neonate)(Up to 28 days after birth)
- Proportion of women who have hospital admission for premature labor(After birth)
- Maternal compliance with treatment(At time of birth)
- Neonatal hospital length of stay (days)(Days from birth to discharge from hospital)
- Neonatal morbidity(Up to 28 days after birth)
- Number of days of assisted ventilation (neonate)(Up to 28 days after birth)
- Adverse events (maternal or neonate)(Up to 28 days after birth)
研究者
Dr. Sue Ross
Associate Professor
University of Calgary