Clinical trial NCT02363569: The Prognosis of Early Pregnancy With Post Coital Bleeding
Official title: The Prognosis of Early Pregnancy With Post Coital Bleeding Compared to Early Pregnancy With Spontaneous Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Bleeding During Pregnancy
Postcoital Bleeding
Keywords: post coital bleeding
vaginal bleeding
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
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)
timeFrame: after they give birth (8 month after they address to the E.R.)
measure: Delivery Complications (cesarean section,assisted delivery)
timeFrame: after they give birth (8 month after they address to the E.R.)
measure: Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)
timeFrame: after they give birth (8 month after they address to the E.R.)
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar saba
country: Israel
facility: Meir Hospital
Study officials:
affiliation: Meir Hospital, Israel
name: Meir Pomeranz, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.