The Prognosis of Early Pregnancy With Post Coital Bleeding

NCT ID: NCT02363569

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-12-31

Brief 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. 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

1. Pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions

2. 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.

Conditions

Vaginal Bleeding During Pregnancy; Postcoital Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meir Pomeranz, M.D

Role: PRINCIPAL_INVESTIGATOR

Meir Hospital, Israel

Locations

Meir Hospital

Kfar Saba, Israel, Israel

Countries

Israel

Central Contacts

Meir Pomeranz, M.D

Role: CONTACT

Pomeranzmiki@clalit.org.il

+972537482770

Danit Aviv

Role: CONTACT

danith1@walla.co.il

+97254967060

References

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.

Reference Type: BACKGROUND

PMID: 9233324 (View on PubMed)

SPEERT 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.

Reference Type: BACKGROUND

PMID: 13162785 (View on PubMed)

Rosenthal 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.

Reference Type: BACKGROUND

PMID: 11212982 (View on PubMed)

Other Identifiers

MeirMc 180-12

Identifier Type: -

Identifier Source: org_study_id