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Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

Primary Purpose

Threatened Abortion

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Dydrogesterone
Placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Threatened Abortion focused on measuring threatened abortion

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton pregnancy with gestational age 6 - 20 weeks
  • threatened abortion
  • confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion Criteria:

  • history of recurrent miscarriage
  • having endocervical polyp
  • having infection such as pneumonia, pyelonephritis, septicemia
  • having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
  • having cancer
  • having coagulation defect
  • allergy to dydrogesterone

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dydrogesterone

Placebo

Arm Description

dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.

Outcomes

Primary Outcome Measures

continue pregnancy more than 20 weeks gestation
percentage of cases with continue pregnancy more than 20 weeks gestation

Secondary Outcome Measures

preterm delivery less than 34 weeks
percentage of delivery less than 34 weeks
preterm delivery less than 37 weeks
percentage of delivery less than 37 weeks
placenta previa
percentage of placenta previa
abruptio placenta
percentage of abruptio placenta
Intrauterine growth restriction
percentage of intrauterine growth restriction
neonatal complications
percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death
side effects
percentage of side effects such as headache, nausea/vomiting
compliance
percentage of complete drug use
maternal satisfaction
percentage of good satisfaction
time until bleeding stops
time from first bleeding until bleeding stops

Full Information

First Posted
March 2, 2021
Last Updated
August 28, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04788108
Brief Title
Oral Progesterone for Prevention of Miscarriage in Threatened Abortion
Official Title
Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Abortion
Keywords
threatened abortion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dydrogesterone
Arm Type
Active Comparator
Arm Description
dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Intervention Description
Dydrogesterone tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
continue pregnancy more than 20 weeks gestation
Description
percentage of cases with continue pregnancy more than 20 weeks gestation
Time Frame
at 20 weeks gestation
Secondary Outcome Measure Information:
Title
preterm delivery less than 34 weeks
Description
percentage of delivery less than 34 weeks
Time Frame
at 34 weeks gestation
Title
preterm delivery less than 37 weeks
Description
percentage of delivery less than 37 weeks
Time Frame
at 37 weeks gestation
Title
placenta previa
Description
percentage of placenta previa
Time Frame
31 weeks
Title
abruptio placenta
Description
percentage of abruptio placenta
Time Frame
31 weeks
Title
Intrauterine growth restriction
Description
percentage of intrauterine growth restriction
Time Frame
31 weeks
Title
neonatal complications
Description
percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death
Time Frame
31 weeks
Title
side effects
Description
percentage of side effects such as headache, nausea/vomiting
Time Frame
6 weeks
Title
compliance
Description
percentage of complete drug use
Time Frame
6 weeks
Title
maternal satisfaction
Description
percentage of good satisfaction
Time Frame
6 weeks
Title
time until bleeding stops
Description
time from first bleeding until bleeding stops
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: singleton pregnancy with gestational age 6 - 20 weeks threatened abortion confirmed intrauterine pregnancy with a viable fetus by ultrasound Exclusion Criteria: history of recurrent miscarriage having endocervical polyp having infection such as pneumonia, pyelonephritis, septicemia having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis having cancer having coagulation defect allergy to dydrogesterone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, M.D.
Organizational Affiliation
Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30157093
Citation
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
Results Reference
background
PubMed Identifier
26800266
Citation
Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.
Results Reference
background
PubMed Identifier
14670641
Citation
Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014.
Results Reference
background
PubMed Identifier
16293412
Citation
Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15.
Results Reference
result
PubMed Identifier
20005647
Citation
Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14.
Results Reference
result
PubMed Identifier
20007011
Citation
El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14.
Results Reference
result

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Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

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