A Phase 3 interventional study of Progesterone in Premature Birth and Twin Pregnancy, sponsored by Chiu Yee Liona Poon. Withdrawn at 4 sites in Hong Kong. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Chiu Yee Liona Poon · Phase 3, Interventional, and Prevention
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.
Randomised studies in singleton pregnancies suggest that the risk of preterm birth can be decreased by using of progesterone. However, in twin pregnancies, no significant reduction in preterm birth has been demonstrated in any trial.
One explanation for the lack of benefit of progesterone in previous twin studies may result from a suboptimal dosage. The investigators therefore hypothesize that progesterone dosages that are sufficient for singleton pregnancies are insufficient for twins and this is likely to be one of the reasons why prophylactic progesterone has failed to reduce preterm birth in twins.
Another possible explanation for the negative findings in previous twin studies may result from administration beginning too late in the second-trimester. It is thought that the mechanism of preterm birth in twin pregnancies is more strongly related to exaggerated uterine distension, which may override any benefit of progesterone on the cervix after a threshold has been reached. It is also plausible that cervical shortening occurs earlier in twin pregnancies than with singletons, and that treatment is required before a threshold of shortening is reached or before any inflammation-mediated component to the initiation of preterm birth has been established as the biological mechanisms by which preterm birth occurs differ from those in singleton pregnancies.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
Browse Premature Birth studies →Chiu Yee Liona Poon is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Start from 11-14 week: 200 mg self-administered vaginal progesterone daily
Drug: Progesterone
Start from 11-14 week: 400 mg self-administered vaginal progesterone daily
Drug: Progesterone
Start from 20-24 week: 200 mg self-administered vaginal progesterone daily
Drug: Progesterone
Start from 20-24 week: 400 mg self-administered vaginal progesterone daily
Drug: Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
Also known as: Utrogestan
The median gestational age (in days) at delivery
Time frame: At delivery
The incidence of spontaneous preterm birth
Time frame: Less than 34 weeks (237 days) of gestation
Birth weight
Time frame: At delivery
Stillbirth or neonatal death due to any cause
Time frame: At delivery
Major adverse outcomes before discharge from the hospital
Intraventricular hemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotizing entercolitis.
Time frame: Within the first year
Need for neonatal special care
Admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion
Time frame: Between birth and 28 days of age
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Chiu Yee Liona Poon