| June 20, 2006 |
| February 25, 2009 |
| June 2006 |
| June 2010 (final data collection date for primary outcome measure) |
| Gestational age [ Time Frame: Delivery ] [ Designated as safety issue: No ] |
| Gestational age |
| Complete list of historical versions of study NCT00343265 on ClinicalTrials.gov Archive Site |
- Proportion of women delivering < 35 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]
- Proportion of women delivering < 37 weeks [ Time Frame: Delivery ] [ Designated as safety issue: No ]
- Proportion of women having spontaneous preterm delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
- Proportion of women having tocolytic therapy [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
- Treatment compliance [ Time Frame: Delivery ] [ Designated as safety issue: No ]
- Length of stay for mother and infants [ Time Frame: Discharge ] [ Designated as safety issue: No ]
- Infant morbidity and mortality [ Time Frame: Discharge ] [ Designated as safety issue: No ]
- Birth weight [ Time Frame: Birth ] [ Designated as safety issue: No ]
|
- Proportion of women delivering < 35 weeks
- Proportion of women delivering < 37 weeks
- Proportion of women having spontaneous preterm delivery
- Proportion of women having tocolytic therapy
- Treatment compliance
- Length of stay for mother and infants
- Infant morbidity and mortality
- Birth weight
|
| |
| Vaginal Progesterone Versus Placebo in Multiple Pregnancy |
| Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy |
The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies. |
Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Preterm Birth |
| Drug: Vaginal progesterone gel and placebo gel |
- Active Comparator: Progesterone gel
- Placebo Comparator: Vaginal gel with no medication
|
| |
| |
| Recruiting |
| 100 |
| June 2010 |
| June 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Confirmed multiple pregnancy
- Ultrasound confirmed minimum of 2 live fetuses
- Gestational age 16-20 6/7 weeks
Exclusion Criteria:
- Placenta previa
- Pre-existing hypertension
- Major fetal anomaly
- Monoamniotic, monozygotic multiples
- Maternal seizure disorder
- History of, or active, thromboembolic disease
- Maternal live disease
- Breast malignancy or pathology
- Progesterone dependent neoplasia
- Plans to move to another city during pregnancy
- Sensitivity to progesterone
- Participation in other clinical trials during the pregnancy
|
| Female |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00343265 |
| Dr. Stephen Wood, University of Calgary |
| 18589, 9427-U0206-47C, 104425 |
| University of Calgary |
- Calgary Health Region
- Columbia Laboratories
|
| Principal Investigator: |
Stephen Wood, MD |
University of Calgary |
|
| Study Director: |
Sue Ross, PhD |
University of Calgary |
|
|
| University of Calgary |
| February 2009 |
