NCT03451136

Brief Summary

This study establishes the relationship between cervical length and whether it can be used to predict haemorrhage and preterm delivery in cases of placenta previa.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

February 5, 2018

Last Update Submit

February 28, 2018

Conditions

Placenta Previa

Keywords

Placenta previaCervical lengthAntepartum haemorrhage

Outcome Measures

Primary Outcomes (1)

  • Cervical length measured in mm in relation to antepartum haemorrhage

    To find out the relationship between cervical length measured by transvaginal ultrasound and occurrence of antepartum hemorrhage in cases of placenta previa.

    4 months

Secondary Outcomes (4)

  • Need for blood transfusion

    4 months

  • Need for caesarean hysterectomy

    4 months

  • Type of cesarean delivery

    4 months

  • Need for neonatal ICU

    4 months

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy pregnant females aged between 25-40 years

You may qualify if:

  • Age: 20-45 years old
  • Single Pregnancy
  • Fetal gestational age 28 to \< 36 weeks
  • Normal amniotic fluid index (AFI)
  • Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).

You may not qualify if:

  • Threatened preterm labor and maternal use of vaginal progesterone.
  • Preterm premature rupture of membranes;
  • Polyhydramnios;
  • Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
  • Diagnosis of multiple fetal anomalies;
  • Women with other risk factors for intra-partum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Marwa Mohamed Eid, PhD

CONTACT

01001225079Marwameid2014@gmail.com

Hisham Mamdouh Haggag, PhD

CONTACT

01224460134Hmhaggag@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.prof obs&Gyn.

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 1, 2018

Study Start

March 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 15, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02