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

M

Menoufia University

Status and phase

Completed
Phase 4

Conditions

Preterm Birth

Treatments

Drug: Aspirin tablet
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05319834
3/2020/OBG

Details and patient eligibility

About

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.

Full 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).

Enrollment

256 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Multifetal pregnancy.
  2. History of ante partum PROM.
  3. Cervical Incompetence or current cervical cerclage.
  4. Known fetal anomaly.
  5. Hypertension requiring medications.
  6. History of Thrombo-embolic disorders.
  7. Known allergy to progesterone or asprin.
  8. Known liver disease.
  9. Established preterm labor
  10. Short cervix

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

256 participants in 2 patient groups, including a placebo group

Progesterone with asprin
Active Comparator group
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),
Treatment:
Drug: Aspirin tablet
Progesterone and placebo
Placebo Comparator group
Description:
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).
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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