Factors Associated With Pregnancy Loss in IVF Women

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02383394

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

17.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.

Condition or Disease	Intervention/Treatment	Phase
Invitro Fertilization	Other: follow up antenatal care

Detailed Description

Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.

Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization

Actual Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
aborted women women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring	Other: follow up antenatal care ultrasound follow up of pregnancy
continued women women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring	Other: follow up antenatal care ultrasound follow up of pregnancy

Arm

Intervention/Treatment

aborted women

women who got pregnant and have 2nd trimesteric abortion, follow up antenatal care by ultrasound and clinical monitoring

Other: follow up antenatal care

ultrasound follow up of pregnancy

continued women

women who got pregnant and completed her pregnancy follow up antenatal care by ultrasound and clinical monitoring

Other: follow up antenatal care

ultrasound follow up of pregnancy

Outcome Measures

Primary Outcome Measures

second trimester abortion [between 12 1/7 and 23 6/7 weeks of gestation)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Exclusion Criteria:

abnormal uterine cavity induced abortion for medical problem

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Maged	Cairo		Egypt	12151

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed Maged, MD, Kasr Alainy medical school

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Maged, Assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT02383394

Other Study ID Numbers:

First Posted:

Mar 9, 2015

Last Update Posted:

Apr 5, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Ahmed Maged, Assistant professor, Cairo University

second trimesteric pregnancy loss

Study Results

No Results Posted as of Apr 5, 2017