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

Sponsor

Menoufia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05319834

Collaborator

(none)

254

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Drug: Aspirin tablet Drug: Placebo	Phase 4

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

254 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

All participants and investigators

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Progesterone with asprin 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),	Drug: Aspirin tablet group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone Other Names: group 1 intervention
Placebo Comparator: Progesterone and placebo 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).	Drug: Placebo group 2: oral placebo once daily at the same time with progesterone Other Names: group 2 intervention

Arm

Intervention/Treatment

Active Comparator: Progesterone with asprin

Drug: Aspirin tablet

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

Other Names:

group 1 intervention

Placebo Comparator: Progesterone and placebo

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).

Drug: Placebo

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

Other Names:

group 2 intervention

Outcome Measures

Primary Outcome Measures

Number of participants who will deliver before 34 weeks gestation. [18 month]
Number of participants who have preterm delivery before 34 weeks gestation

Secondary Outcome Measures

The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation [18 months]
Number of participants who will deliver after 34w gestation and neonatal outcomes
Neonatal outcomes [18 months]
Neonatal birth weight Admission to NICU Neonatal complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Maher, Professor, Menoufia University

ClinicalTrials.gov Identifier:

NCT05319834

Other Study ID Numbers:

3/2020/OBG

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Premature Birth

Aspirin

Study Results

No Results Posted as of Apr 8, 2022