Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02128685
• Collaborator: (none)
• Enrollment: 406
• Locations: 3
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 135.3
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The aim of this study is to determine whether the dydrogesterone therapy is associated with reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women with threatened miscarriage.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: Dydrogesterone; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 406 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Women With Threatened Miscarriage in the First Trimester
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dydrogesterone Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer.	Drug: Dydrogesterone; Other Names: Duphaston
Placebo Comparator: Placebo pill Patients allocated to the dydrogesterone group will receive oral dydrogesterone 40mg stat, followed by 10mg orally three times a day, and placebo will be used in the control group accordingly. Patients will be followed up with weekly pelvic ultrasound till 12 completed weeks of gestation or 1 week after the bleeding stopped, whichever is longer.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. The chance of miscarriage before 20 weeks of gestation [At 20 weeks of gestation]

Secondary Outcome Measures

1. Live birth rate [At the time of delivery, from 24 weeks of gestation till term gestation]

2. The proportion of heavy vaginal bleeding or severe abdominal pain requiring surgical intervention (<20 weeks) [Before 20 weeks of gestation]

3. The incidence of antepartum hemorrhage [From 24 weeks of gestation till term]

   Any vaginal bleeding during pregnancy from the 24th week gestational age to term

4. The incidence of placenta previa [From 24 weeks of gestation till term]

   Placenta is being inserted partially or wholly in the lower uterine segment and will be diagnosed by antenatal ultrasound at second and third trimesters

5. The incidence of pregnancy-induced hypertension [From 20 weeks of gestation till term]

   Any development of newly-onset hypertension (blood pressure persistently >=140/90mmHg on two occasions at least 4 hours apart) during pregnancy after 20 weeks gestation, labour or the puerperium in a previously normotensive non-proteinuric women

6. The incidence of intrauterine death [After 24 weeks of gestation till term]

   Fetus dies in uterus after 24 weeks gestation

7. The incidence of preterm labour [From 24 weeks to 36 weeks gestation]

   Any premature spontaneous delivery from 24 weeks to 36 weeks gestation

8. Low birth weight at term (grams) [After 37 weeks gestation]

   Baby born with birth weight less than 2500g at or after 37 weeks gestation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age of women from 18-40 years at the time of recruitment (not beyond 40th birthday)

• Absence of fever

• Gestation less than 12 completed weeks as defined by pelvic ultrasound

• Presence of intrauterine gestational sac(s) if an urine pregnancy test is first positive within past 2 weeks

• Presence of intrauterine fetus(es) with crown-rump length of <7mm and no fetal pulsation, or presence of intrauterine fetus(es) with positive fetal heart pulsation confirmed on pelvic scanning

Exclusion Criteria:

• Age of women >40 years at the time of recruitment

• History of recurrent miscarriage defined as at least three consecutive spontaneous miscarriages

• History of known parental chromosomal abnormalities

• Heavy vaginal bleeding requiring surgical intervention

• Severe abdominal pain requiring surgical intervention

• Absence of cardiac pulsation in a fetal pole with crown-rump length of >=7mm on transvaginal scanning

• Use of hCG or progesterone treatment for threatened miscarriage prior to recruitment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynaecology, PYNEH	Chai Wan		Hong Kong
2	Department of Obstetrics & Gynaecology, Queen Mary Hospital	Hong Kong		Hong Kong
3	Department of Obstetrics & Gynaecology, Kwong Wah Hospital	Mong Kok		Hong Kong

Sponsors and Collaborators

• The University of Hong Kong

Investigators

• Principal Investigator: Man Ka Diana Chan, MBBS(HK), Department of Obstetrics & Gynaecology, Queen Mary Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Diana Man-Ka Chan, Resident, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT02128685
• Other Study ID Numbers: UW 13-292
• First Posted: May 1, 2014
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Dr. Diana Man-Ka Chan, Resident, The University of Hong Kong: Threatened miscarriage; Dydrogesterone; Randomized controlled trial
• Additional relevant MeSH terms: Abortion, Spontaneous; Abortion, Threatened; Dydrogesterone

Study Results

No Results Posted as of Oct 16, 2018