Progesterone to Prevent Preterm Delivery
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|ClinicalTrials.gov Identifier: NCT03428685|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 10, 2019
Preterm birth (PTB) is a major challenge to perinatal health. It is defined as delivery before 37 completed gestational weeks. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities, and it is the second most common cause of death in children under the age of 5 year. Neonates born preterm are at risk of respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. It is estimated that the societal cost of PTB is $26 billion annually in the USA alone.
Until now, prevention or reduction of PTB is based on identification of risk factors in obstetrical history, biochemical markers and short cervix. History of PTB and asymptomatic short cervix at the second trimester are both strong predictors for PTB. In women with asymptomatic short cervix at the second trimester, vaginal progesterone could effectively reduce PTB. Universal cervical length screening followed by treatment with vaginal progesterone has been shown to be the most cost effective strategy in preventing PTB. These findings were confirmed in meta-analysis.
Nevertheless, only minority of women may benefit from progesterone treatment if it was being started at the second trimester. There is still a large proportion of PTB, which is currently not preventable, and the current approach to prevent PTB is far from ideal.
One possible hypothesis is that the initiation of progesterone treatment would be too late for its effect to take place. Therefore, we decide to use oral progesterone in the current study. The objective of the study is to determine whether early use of progesterone can prevent PTB better when compared with universal screening of cervical length and followed by treatment with progesterone in those with short cervix.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Drug: Dydrogesterone Oral Tablet Drug: Placebo Oral Tablet||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1714 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blinded Randomized Controlled Trial of Early Use of Oral Progesterone in All Women for Prevention of Preterm Delivery in Singleton Pregnancy (SINPRO Study)|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2023|
|Active Comparator: Intervention group||
Drug: Dydrogesterone Oral Tablet
Oral dysdrogesteone 10mg tds will be prescribed from 12 - 36+6 weeks.
|Placebo Comparator: Placebo group||
Drug: Placebo Oral Tablet
Placebos will be prescribed from 12 - 36+6 weeks.
- Rate of preterm delivery [ Time Frame: before 37+0 gestational weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428685
|China, Hong Kong|
|Department of Obstetrics and Gynaecology||Recruiting|
|Hong Kong, Hong Kong, China, 852|
|Contact: Ka Wang Cheung (852) 22553111 firstname.lastname@example.org|