The Prognosis of Early Pregnancy With Post Coital Bleeding

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Bleeding During Pregnancy; Postcoital Bleeding

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Meir Pomeranz, M.D; Phone Number: +972537482770; Email: Pomeranzmiki@clalit.org.il
• Study Contact Backup: Name: Danit Aviv; Phone Number: +97254967060; Email: danith1@walla.co.il

Study Locations

• Israel
  • Kfar saba, Israel
    • Meir Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with early pregnancy (4-23 weeks) with singletons or twins that address to the "Women E.R." due to vaginal bleeding.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	after they give birth (8 month after they address to the E.R.)
Delivery Complications (cesarean section,assisted delivery)	cesarean section,assisted delivery.	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	after they give birth (8 month after they address to the E.R.)

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Meir Pomeranz, M.D, Meir Hospital, Israel

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (ESTIMATE): February 16, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: post coital bleeding; vaginal bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: MeirMc 180-12