Progesterone to Prevent Preterm Delivery

NCT03428685 | Unknown Phase 2

• 1 other identifier: UW 17-308
• Study Type: interventional
• Target: 1,714
• Locations: 1 country
• Sites: 1

Brief 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

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Rate of preterm delivery

  before 37+0 gestational weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Drug: Dydrogesterone Oral Tablet

Placebo group

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Dydrogesterone Oral Tablet DRUG

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

Intervention group

Placebo Oral Tablet DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women age ≥ 18 years old
• Confirmed intrauterine singleton pregnancy
• Gestational age less than 14 completed weeks as defined by pelvic ultrasound

You may not qualify if:

• Silent miscarriage: mean gestational sac diameter ≥25 mm without fetal pole, or embryo with crown rump length ≥7 mm and no heartbeat, or no interval growth
• Suspected ectopic pregnancy
• Multiple pregnancy with silent miscarriage of one twin
• Heavy vaginal bleeding requiring surgical intervention
• Severe abdominal pain requiring surgical intervention
• Presence of fever
• History of adverse reaction to progesterone
• History of breast or genital tract malignancy
• History of suspected thromboembolic disease
• Congenital uterine anomaly
• Unwillingness or inability to comply with study procedures
• Known paternal or maternal abnormal karyotype

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, 852, China

RECRUITING

Related Publications (1)

• Cheung KW, Seto MTY, Ng EHY. Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2020 Jan 30;21(1):121. doi: 10.1186/s13063-020-4067-z.

  PMID: 32000820 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 12, 2018
• Study Start: January 15, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CN (1)