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Progesterone to Prevent Preterm Delivery

NCT03428685 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1714

Last updated 2019-04-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dydrogesterone Oral Tablet

Oral dysdrogesteone 10mg tds will be prescribed from 12 - 36+6 weeks.

DRUG

Placebo Oral Tablet

Placebos will be prescribed from 12 - 36+6 weeks.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2021-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428685 on ClinicalTrials.gov