Vaginal Progesterone Against a Second Attack of Antepartum Haemorrhage in Placenta Previa Women

NCT04725929 | Completed

• 1 other identifier: Placenta Previa
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta praevia is associated with an increased risk of preterm delivery (PTD) especially if associated with bleeding and uterine contractions . In this study we will determine the effect of Progesterone in preventing a second attack of antepartum haemorrhage in pregnant women diagnosed with placenta previa

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• patient with past history of antepartum haemorrhage will not have a secondary attack

  decrease the bleeding

  2 weeks

Secondary Outcomes (1)

• duration between first and secondary attack

  2 week

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

* Group I, vaginal Progesterone (Vaginal progesterone "prontogest 400 MG") Once Daily starting from 24 to 34 weeks of gestation or rectal progesterone if the patient fears of taking vaginal or still have bleeding, * Group II, included placenta praevia patients receivinv placebo

You may qualify if:

• o Women diagnosed as placenta previa.
• Women aged 20-40 years, who were pregnant in a single foetus
• Gestational age ranging between 24 and 34 weeks
• Patient had attack of Antepartum Haemorrhage or history of Antepartum Haemorrhage

You may not qualify if:

• o History of previous PTD
• Polyhydramnios
• Severe attack of bleeding requiring an immediate intervention
• Intrauterine foetal death

Sponsors & Collaborators

• Nourhan Ashraf ElSherbiny: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Mahmoud Ghaleb, MD

  Ain Shams Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The principal.investigator

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

EG (1)