Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04788108
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Threatened Abortion	Drug: Dydrogesterone; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial
• Actual Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dydrogesterone dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.	Drug: Dydrogesterone; Dydrogesterone tablet
Placebo Comparator: Placebo placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks.	Drug: Placebo; Placebo tablet

Outcome Measures

Primary Outcome Measures

1. continue pregnancy more than 20 weeks gestation [at 20 weeks gestation]

   percentage of cases with continue pregnancy more than 20 weeks gestation

Secondary Outcome Measures

1. preterm delivery less than 34 weeks [at 34 weeks gestation]

   percentage of delivery less than 34 weeks

2. preterm delivery less than 37 weeks [at 37 weeks gestation]

   percentage of delivery less than 37 weeks

3. placenta previa [31 weeks]

   percentage of placenta previa

4. abruptio placenta [31 weeks]

   percentage of abruptio placenta

5. Intrauterine growth restriction [31 weeks]

   percentage of intrauterine growth restriction

6. neonatal complications [31 weeks]

   percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death

7. side effects [6 weeks]

   percentage of side effects such as headache, nausea/vomiting

8. compliance [6 weeks]

   percentage of complete drug use

9. maternal satisfaction [6 weeks]

   percentage of good satisfaction

10. time until bleeding stops [6 weeks]

    time from first bleeding until bleeding stops

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

• Study Director: Vorapong Phupong, M.D., Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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. Review.

• Responsible Party: Vorapong Phupong, Head of Placental Related Diseases Research Unit, Principal Investigator, Professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT04788108
• Other Study ID Numbers: 177/2021
• First Posted: Mar 9, 2021
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vorapong Phupong, Head of Placental Related Diseases Research Unit, Principal Investigator, Professor, Chulalongkorn University: threatened abortion
• Additional relevant MeSH terms: Abortion, Spontaneous; Abortion, Threatened; Dydrogesterone

Study Results

No Results Posted as of Mar 16, 2022