NCT02383394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

March 4, 2015

Last Update Submit

April 4, 2017

Conditions

Keywords

second trimesteric pregnancy loss

Outcome Measures

Primary Outcomes (1)

  • second trimester abortion

    between 12 1/7 and 23 6/7 weeks of gestation)

Study Arms (2)

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

continued women

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

Other: follow up antenatal care

Interventions

ultrasound follow up of pregnancy

aborted womencontinued women

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • abnormal uterine cavity induced abortion for medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Maged

Cairo, 12151, Egypt

RECRUITING

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Maged, MD

CONTACT

Adel Nada, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 9, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations