Progesterone and Second Trimester Bleeding

The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01269450

Enrollment

128

Registered

2011-01-04

Start date

2011-03-31

Completion date

2017-07-31

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antepartum Bleeding, Preterm Birth

Keywords

second trimester vaginal bleeding, late abortion, preterm birth, progesterone

Brief summary

Working hypothesis and aims: To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding. The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.

Interventions

DRUGmicronized progesterone 200 mg (Utrogestan)

micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily

DRUGplacebo

placebo 200mg vaginal tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Viable pregnancy * Gestational age between 13 to 26 weeks * Vaginal bleeding from uterine origin * Singleton pregnancy * Normal clotting tests * Hemodynamically stable woman

Exclusion criteria

* Water leak * Signs of preterm labor * Fetal malformations incompatible with life * Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state * Past preterm birth

Design outcomes

Primary

Measure	Time frame
Incidence of spontaneous preterm birth - before 37 weeks.	3 years

Secondary

Measure	Time frame
Maternal and fetal outcomes	3 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026