Antepartum BleedingNCT01269450
Progesterone and Second Trimester Bleeding
A study testing micronized progesterone 200 mg (Utrogestan) in people with Antepartum Bleeding and Preterm Birth, run by HaEmek Medical Center, Israel at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Antepartum Bleeding, Preterm Birth
- What is being tested?
- micronized progesterone 200 mg (Utrogestan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesIsrael
- Study dates
- Mar 2011to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Viable pregnancy
- Gestational age between 13 to 26 weeks
- Vaginal bleeding from uterine origin
- Singleton pregnancy
- Normal clotting tests
- Hemodynamically stable woman
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Emek medical center
Afula, 18101
dEP ob/gyn, Hillel Yaffe Medical Center.
Hadera
Dep. OB/GYN, The Nazareth Hospital, E.M.M.S
Nazareth
About this study
Official title: The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
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.
- Conditions
- Antepartum Bleeding, Preterm Birth
- Being tested
- micronized progesterone 200 mg (Utrogestan), placebo
- Keywords
- second trimester vaginal bleeding, late abortion, preterm birth, progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized progesterone 200 mg (Utrogestan)Drug
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
placeboDrug
placebo 200mg vaginal tablets
| Study group | Role | What they receive |
|---|---|---|
| Utrogestan | Active comparator | Not described Receives: Drug: micronized progesterone 200 mg (Utrogestan) |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spontaneous preterm birth - before 37 weeks.
Measured: 3 years
Secondary outcomes (1)
Maternal and fetal outcomes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2017
- Study completionJul 2017
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antepartum BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- RAED SALIM, MD, Principal investigator, HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269450
- Sponsor's protocol ID
- 0023-08-EMC
- Status last verified
- Jun 2018
- First submitted
- 3 Jan 2011
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.
PubMed 31087325
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01269450
- Acronym / sponsor ID
- 0023-08-EMC
- Conditions
- Antepartum Bleeding, Preterm Birth
- Keywords
- second trimester vaginal bleeding, late abortion, preterm birth, progesterone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 128 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Utrogestan | Active comparator | Drug: micronized progesterone 200 mg (Utrogestan) |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Viable pregnancy
- Gestational age between 13 to 26 weeks
- Vaginal bleeding from uterine origin
- Singleton pregnancy
- Normal clotting tests
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronized progesterone 200 mg (Utrogestan)micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily | Drug | Utrogestan |
| placeboplacebo 200mg vaginal tablets | Drug | placebo |
Primary outcome
Incidence of spontaneous preterm birth - before 37 weeks.
Time frame: 3 years
1 secondary outcome
Maternal and fetal outcomes
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 31087325Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.
Related trials for Antepartum Bleeding
Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Placenta Previa, Placenta Accreta Spectrum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAED SALIM, MD principal investigator
HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micronized progesterone 200 mg (Utrogestan) in people with Antepartum Bleeding and Preterm Birth, run by HaEmek Medical Center, Israel at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of spontaneous preterm birth - before 37 weeks. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.