Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor (PROTO)
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.
|Obstetric Labor, Premature||Drug: Vaginal progesterone Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor|
- Gestational age at birth [ Time Frame: At birth ]Gestational age at birth calculated from gestational age at pre-randomization baseline
- Proportion of women who have preterm birth <35 weeks [ Time Frame: At birth ]
- Proportion of women who have a preterm birth at <37 weeks [ Time Frame: At birth ]
- Maternal hospital length of stay (days) [ Time Frame: Days from date of admission to date of discharge ]
- Proportion of women who have hospital admission for premature labor [ Time Frame: After birth ]
- Maternal compliance with treatment [ Time Frame: At time of birth ]Diary self-report of treatment use
- Neonatal hospital length of stay (days) [ Time Frame: Days from birth to discharge from hospital ]
- Neonatal morbidity [ Time Frame: Up to 28 days after birth ]Respiratory distress syndrome (type 1), intraventricular hemorrhage, chronic lung disease, periventricular leukomalacia,necrotising eneterocolitis, retinopathy of prematurity
- Number of days of assisted ventilation (neonate) [ Time Frame: Up to 28 days after birth ]
- Number of days of supplemental oxygen (for neonate) [ Time Frame: Up to 28 days after birth ]
- Birth weight (grams) [ Time Frame: At time of birth ]
- Neonatal survival to discharge home (yes/no) [ Time Frame: During 28 days after birth ]
- Adverse events (maternal or neonate) [ Time Frame: Up to 28 days after birth ]
|Study Start Date:||January 2011|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Experimental: Vaginal progesterone||
Drug: Vaginal progesterone
Capsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
Other Name: Utrogestan
|Placebo Comparator: Placebo||
Capsules of placebo (sunflower oil). One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286246
|Foothills Medical Centre|
|Calgary, Alberta, Canada, T2N 4J8|
|Principal Investigator:||Stephen Wood, MD, MSc||University of Calgary|