The Prognosis of Early Pregnancy With Post Coital Bleeding

• Conditions: Vaginal Bleeding During Pregnancy; Postcoital Bleeding

• Registration Number: NCT02363569
• Lead Sponsor: Meir Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-12
• Study Start: 2015-02
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Study First Posted: 2015-02-16
• Last Update Posted: 2015-02-16
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delivery Complications (cesarean section,assisted delivery)	after they give birth (8 month after they address to the E.R.)	cesarean section,assisted delivery.
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)	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
Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)	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

Trial Locations

Locations (1)

Meir Hospital; 🇮🇱 Kfar saba, Israel