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A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations

Ahmed S. Abdel Wahab, Mostafa I. Abdelmonaem, Walaa M. Mahmoud and Ahmed E. Mansour

Abstract

Objectives

To compare between the effectiveness and safety of two different daily doses of vaginal progesterone (400 vs. 200 mg) in the prevention of preterm labor in twin pregnancy.

Methods

This is a prospective single-blinded randomized controlled trial conducted on 100 primi-gravida who had twin pregnancy and attended the antenatal clinic of a University hospital. They were equally and randomly allocated into two arms each containing 50 patients. Arm 1 received 400 mg and arm 2 received 200 mg vaginal progesterone daily at bed time starting from 14 weeks of pregnancy to 36 weeks. Transvaginal ultrasound was performed for assessment of the length of cervix at 14 and 22 weeks.

Results

Both arms of the current study were comparable regarding the cervical length at 14 and 22 weeks, mean gestational age at delivery, incidence of pre-term delivery, birth weight of the first twin. Second twin in addition to the average weight of both twins. No statistical significance differences between two arms regarding incidence of early neonatal death. NICU, mechanical ventilation, length of admission in NICU for the first twin. Second twin as well as both twins.

Conclusions

Vaginal progesterone treatment with different doses was tolerable, but wasn’t effective in the prevention of preterm labor in twin pregnancy.


Corresponding author: Walaa M. Mahmoud, Department of Obstetrics and Gynecology, Ras-Eltein Hospital, Alexandria, Egypt, Phone: +201023702749, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The local Institutional Review Board of Ain-Shams University approved the study.

  6. Trial registration number:ClinicalTrials.gov. I.D. Number MS 483/2019.

  7. Data availability: Available upon request but cannot be deposited in a trial repository for privacy issues.

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Received: 2021-03-23
Accepted: 2021-07-29
Published Online: 2021-09-14

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