Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

Obstetric Labor, Premature Clinical Trial

— PROTO  

Official title:

Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01286246
• Other study ID #: 21492
• Status: Terminated
• Phase: Phase 4
• First received: January 27, 2011
• Last updated: January 7, 2015
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor, Premature

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at birth	Gestational age at birth calculated from gestational age at pre-randomization baseline	At birth	No
Secondary	Proportion of women who have preterm birth <35 weeks		At birth	No
Secondary	Proportion of women who have a preterm birth at <37 weeks		At birth	No
Secondary	Maternal hospital length of stay (days)		Days from date of admission to date of discharge	No
Secondary	Proportion of women who have hospital admission for premature labor		After birth	No
Secondary	Maternal compliance with treatment	Diary self-report of treatment use	At time of birth	No
Secondary	Neonatal hospital length of stay (days)		Days from birth to discharge from hospital	No
Secondary	Neonatal morbidity	Respiratory distress syndrome (type 1), intraventricular hemorrhage, chronic lung disease, periventricular leukomalacia,necrotising eneterocolitis, retinopathy of prematurity	Up to 28 days after birth	No
Secondary	Number of days of assisted ventilation (neonate)		Up to 28 days after birth	No
Secondary	Number of days of supplemental oxygen (for neonate)		Up to 28 days after birth	No
Secondary	Birth weight (grams)		At time of birth	No
Secondary	Neonatal survival to discharge home (yes/no)		During 28 days after birth	No
Secondary	Adverse events (maternal or neonate)		Up to 28 days after birth	Yes