NCT03251794

Brief Summary

Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003. Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at \< 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

August 13, 2017

Last Update Submit

June 26, 2018

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • the volume of adrenal gland

    measurement by three dimensional ultrasound

    5 minutes

Study Arms (1)

threatened preterm labor

women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix

Diagnostic Test: three dimensional ultrasoundDiagnostic Test: color Doppler

Interventions

three dimensional ultrasoundDIAGNOSTIC_TEST

evaluation of the suprarenal glands

threatened preterm labor
color DopplerDIAGNOSTIC_TEST

Doppler evaluation of the suprarenal artery

threatened preterm labor

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with threatened preterm labor

You may qualify if:

  • singleton fetus less than 37 weeks of gestation
  • women diagnosed to having Threatened preterm labor.
  • presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
  • cervical effacement \<80 %
  • cervical dilatation \<1 cm

You may not qualify if:

  • suspected fetal growth restriction,
  • maternal medical complications,
  • presence of fetal heart rate abnormalities at enrollment.
  • Preterm Premature rupture of membranes
  • Placenta previa
  • Lower urinary tract infection or genital infection
  • Fetal congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 13, 2017

First Posted

August 16, 2017

Study Start

March 1, 2017

Primary Completion

March 15, 2018

Study Completion

April 18, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

EG(1)