Progesterone to Prevent Preterm Delivery

• ClinicalTrials.gov Identifier: NCT03428685
• Recruitment Status: Unknown
• First Posted: February 12, 2018
• Last Update Posted: April 10, 2019
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): Dr. Cheung Ka Wang, The University of Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Birth	Drug: Dydrogesterone Oral Tablet; Drug: Placebo Oral Tablet	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1714 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Rate of preterm delivery [ Time Frame: before 37+0 gestational weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

China, Hong Kong

Department of Obstetrics and Gynaecology; Recruiting

Hong Kong, Hong Kong, China, 852

Contact: Ka Wang Cheung (852) 22553111 kelvincheung82@hotmail.com

Sponsors and Collaborators

The University of Hong Kong

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr. Cheung Ka Wang, Associate Consultant, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03428685
• Other Study ID Numbers: UW 17-308
• First Posted: February 12, 2018
• Last Update Posted: April 10, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dydrogesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs