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Register:	ChiCTR
Last refreshed on:	18 April 2017
Main ID:	ChiCTR-IPR-14005251
Date of registration:	2014-09-21
Prospective Registration:	No
Primary sponsor:	KK Women's and Children's Hospital
Public title:	Micronised progesterone versus dydrogesterone: A randomised controlled trial
Scientific title:	Progestogen for threatened miscarriage: A randomised controlled trial comparing micronised progester
Date of first enrolment:	2014-01-13
Target sample size:	Micronised progesterone:41;Dydrogesterone:42;
Recruitment status:	Completed
URL:	http://www.chictr.org.cn/showproj.aspx?proj=9539
Study type:	Interventional study
Study design:	Randomized parallel controlled trial
Phase:	I (Phase I study)

Countries of recruitment
China

Contacts

Name:	Tan Thiam Chye
Address:	100 Bukit Timah Rd, Singapore 229899
Telephone:	+65 81211679
Email:	tan.thiam.chye@kkh.com.sg
Affiliation:

Name:	Shayna Siew
Address:	40 Wan Tho Avenue, Singapore 347582
Telephone:	+65 91285225
Email:	jiayun89@gmail.com
Affiliation:	Duke-NUS Graduate Medical School

Key inclusion & exclusion criteria

Inclusion criteria: 1.Single intrauterine fetus (confirmed by ultrasonography)
2.Women presenting with pregnancy-related per vagina bleeding
3.Gestation weeks 6 to 10 (confirmed by ultrasonography)
Exclusion criteria: 1.Treated with progesterone for previous per vagina bleeding in this current pregnancy;
2.Treated with progesterone for any other medical reasons in this current pregnancy;
3.Women diagnosed with inevitable miscarriage;
4.Women planning to terminate the pregnancy;
5.Women who are known to have recurrent miscarriages (3 or more consecutive pregnancy loss before 24 weeks of gestation);
6.Women who have pre-existing luteal phase deficiency or other forms of diagnosed progesterone deficiency.

Age minimum: 21
Age maximum: 45
Gender:

Health Condition(s) or Problem(s) studied

Threatened Miscarriage

Intervention(s)

Micronised progesterone:Micronised progesterone;Dydrogesterone:Dydrogesterone;

Primary Outcome(s)

Serum progesterone;Serum PIBF;Miscarriage;Bleeding pattern;Side effects;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Khoo Student Research Award

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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