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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
Sponsor:
Information provided by (Responsible Party):
Dr. Cheung Ka Wang, The University of Hong Kong

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

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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

Resource links provided by the National Library of Medicine


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.




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


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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

Information from the National Library of Medicine

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


Locations
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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

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

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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:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs