Vaginal Bleeding During PregnancyNCT02363569
The Prognosis of Early Pregnancy With Post Coital Bleeding
An observational study of Vaginal Bleeding During Pregnancy and Postcoital Bleeding, run by Meir Medical Center at 1 site in Israel.
Trial summary
This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vaginal Bleeding During Pregnancy, Postcoital Bleeding
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2015to Dec 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with early pregnancy (4-23 weeks) with singletons or twins that address to the "Women E.R." due to vaginal bleeding.
Who may be able to join
- women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding.
Who cannot join
- age >40 or <18
- women with history of more then 3 abortions.
- women with history of more then 2 pre term labor
- ectopic pregnancy
- placental previa
- women who takes anticoagulation therapy
- women with known pathology at cervix.
- women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognosis of Early Pregnancy With Post Coital Bleeding Compared to Early Pregnancy With Spontaneous Bleeding
This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.
Read the detailed description
This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women E.R" at "Meir" Hospital due to spontaneous -or after intercourse bleeding - bleeding secretions. The women will be divided in to two groups
- Pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions
- Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.
The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy) The doctor that had examined the women, will have to fill out questionnaires regarding the bleeding source, the time after intercourse, how long after the intercourse the bleeding had appeared and which kind of examination he had carried out.
A month after their appeal to the E.R. and after they give birth ,the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups, by phone.
- Keywords
- post coital bleeding, vaginal bleeding
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case- | Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse. | |
| control | Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed the "women ER" due to spontaneous bleeding or bleeding secretions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Complications (abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension)
abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension
Measured: after they give birth (8 month after they address to the E.R.)
Delivery Complications (cesarean section,assisted delivery)
cesarean section,assisted delivery.
Measured: after they give birth (8 month after they address to the E.R.)
Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)
low apgar, small gestational age , need for blood transfusion, artificial respiration, infection
Measured: after they give birth (8 month after they address to the E.R.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal Bleeding During PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meir Pomeranz, M.D, Principal investigator, Meir Hospital, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363569
- Sponsor's protocol ID
- MeirMc 180-12
- Status last verified
- Dec 2014
- First submitted
- 2 Feb 2015
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospective study from general practice. BMJ. 1997 Jul 5;315(7099):32-4. doi: 10.1136/bmj.315.7099.32.
PubMed 9233324SPEERT H, GUTTMACHER AF. Frequency and significance of bleeding in early pregnancy. J Am Med Assoc. 1954 Jun 19;155(8):712-5. doi: 10.1001/jama.1954.03690260004002. No abstract available.
PubMed 13162785Rosenthal AN, Panoskaltsis T, Smith T, Soutter WP. The frequency of significant pathology in women attending a general gynaecological service for postcoital bleeding. BJOG. 2001 Jan;108(1):103-6. doi: 10.1111/j.1471-0528.2001.00008.x.
PubMed 11212982
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognosis of Early Pregnancy With Post Coital Bleeding Compared to Early Pregnancy With Spontaneous Bleeding
- ClinicalTrials.gov ID
- NCT02363569
- Acronym / sponsor ID
- MeirMc 180-12
- Keywords
- post coital bleeding, vaginal bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Feb 2015 (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.
This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.
Detailed description
This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women E.R" at "Meir" Hospital due to spontaneous -or after intercourse bleeding - bleeding secretions. The women will be divided in to two groups
- Pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions
- Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.
The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy) The doctor that had examined the women, will have to fill out questionnaires regarding the bleeding source, the time after intercourse, how long after the intercourse the bleeding had appeared and which kind of examination he had carried out.
A month after their appeal to the E.R. and after they give birth ,the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups, by phone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case- | – | –Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse. |
| control | – | –Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed the "women ER" due to spontaneous bleeding or bleeding secretions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with early pregnancy (4-23 weeks) with singletons or twins that address to the "Women E.R." due to vaginal bleeding.
Key inclusion criteria (1 listed)
- women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding.
Key exclusion criteria (8 listed)
- age >40 or <18
- women with history of more then 3 abortions.
- women with history of more then 2 pre term labor
- ectopic pregnancy
- placental previa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy Complications (abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension)
Time frame: after they give birth (8 month after they address to the E.R.)
abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension
Delivery Complications (cesarean section,assisted delivery)
Time frame: after they give birth (8 month after they address to the E.R.)
cesarean section,assisted delivery.
Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)
Time frame: after they give birth (8 month after they address to the E.R.)
low apgar, small gestational age , need for blood transfusion, artificial respiration, infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Background: PubMed 9233324Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospective study from general practice. BMJ. 1997 Jul 5;315(7099):32-4. doi: 10.1136/bmj.315.7099.32.
- Background: PubMed 13162785SPEERT H, GUTTMACHER AF. Frequency and significance of bleeding in early pregnancy. J Am Med Assoc. 1954 Jun 19;155(8):712-5. doi: 10.1001/jama.1954.03690260004002. No abstract available.
- Background: PubMed 11212982Rosenthal AN, Panoskaltsis T, Smith T, Soutter WP. The frequency of significant pathology in women attending a general gynaecological service for postcoital bleeding. BJOG. 2001 Jan;108(1):103-6. doi: 10.1111/j.1471-0528.2001.00008.x.
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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.
Meir Pomeranz, M.D principal investigator
Meir Hospital, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Bleeding During Pregnancy and Postcoital Bleeding, run by Meir Medical Center at 1 site 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meir Pomeranz, M.D (+972537482770, Pomeranzmiki@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Complications (abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension) (time frame: after they give birth (8 month after they address to the E.R.)). The study lists 3 primary outcomes in all. 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 NCT02363569, which also lists 3 linked publications.
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 16 Feb 2015.