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OpenTrials
Completed

NCT Number: NCT05319834

Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth

This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Menoufia University

Shibīn al Kawm, Egypt

About this study

The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women of any age
  • Any parity
  • Healthy singleton pregnancy
  • History suggestive of one or more previous PTB
  • Current pregnancy (16-20) weeks gestation.

Exclusion criteria

  • Multifetal pregnancy.
  • History of ante partum PROM.
  • Cervical Incompetence or current cervical cerclage.
  • Known fetal anomaly.
  • Hypertension requiring medications.
  • History of Thrombo-embolic disorders.
  • Known allergy to progesterone or asprin.
  • Known liver disease.
  • Established preterm labor
  • Short cervix

Treatment and study plan

Aspirin tablet

Drug

group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone

Other names: group 1 intervention

Placebo

Drug

group 2: oral placebo once daily at the same time with progesterone

Other names: group 2 intervention

Primary outcomes

  1. Number of participants who will deliver before 34 weeks gestation.

    Time frame: 18 month

    Number of participants who have preterm delivery before 34 weeks gestation

Secondary outcomes

  1. The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation

    Time frame: 18 months

    Number of participants who will deliver after 34w gestation and neonatal outcomes

  2. Neonatal outcomes

    Time frame: 18 months

    Neonatal birth weight Admission to NICU Neonatal complications

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Acronym: prematurity

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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