Premature Birth Clinical Trial
— POPPETOfficial title:
Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)
NCT number | NCT03540225 |
Other study ID # | 2016.594-T |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 2020 |
Est. completion date | December 2022 |
Verified date | January 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Dichorionic diamniotic (DCDA) pregnancies - Live fetuses at 11-13 weeks of gestation, - Informed and written consent Exclusion Criteria: - High-risk for aneuploidies, - Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment, - Hypersensitivity to progesterone, - Women taking progesterone regularly or at any time within the previous 7 days, - Concurrent participation in another drug trial or at any time within the previous 28 days, - Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, - Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Kwong Wah Hospital | Hong Kong | |
Hong Kong | Prince of Wales Hospital | Hong Kong | |
Hong Kong | Princess Margaret Hospital | Hong Kong | |
Hong Kong | Queen Elizabeth Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chiu Yee Liona Poon |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The median gestational age (in days) at delivery | At delivery | ||
Secondary | The incidence of spontaneous preterm birth | Less than 34 weeks (237 days) of gestation | ||
Secondary | Birth weight | At delivery | ||
Secondary | Stillbirth or neonatal death due to any cause | At delivery | ||
Secondary | Major adverse outcomes before discharge from the hospital | Intraventricular hemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotizing entercolitis. | Within the first year | |
Secondary | Need for neonatal special care | Admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion | Between birth and 28 days of age |
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