A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations
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Ahmed S. Abdel Wahab
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.
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Research funding: None declared.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The local Institutional Review Board of Ain-Shams University approved the study.
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Trial registration number: ClinicalTrials.gov. I.D. Number MS 483/2019.
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Data availability: Available upon request but cannot be deposited in a trial repository for privacy issues.
References
1. Liu, L, Oza, S, Hogan, D, Chu, Y, Perin, J, Zhu, J, et al.. Global, regional, and national causes of under-5 mortality in 2000–15: an updated systematic analysis with implications for the sustainable development goals. Lancet 2016;388:3027–35. https://doi.org/10.1016/s0140-6736(16)31593-8.Search in Google Scholar
2. Saigal, S, Doyle, L. Preterm birth 3. An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet 2008;371:261–9. https://doi.org/10.1016/s0140-6736(08)60136-1.Search in Google Scholar
3. Goldenberg, R, Culhane, J, Iams, J, Romero, R. Preterm birth 1. Epidemiology and causes of preterm birth. Lancet 2008;371:75–84. https://doi.org/10.1016/s0140-6736(08)60074-4.Search in Google Scholar
4. Iams, J, Romero, R, Culhane, J, Goldenberg, R. Preterm birth 2. Primary, secondary and tertiary interventions to reduce the morbidity and mortality of preterm birth. Lancet 2008;371:164–75. https://doi.org/10.1016/s0140-6736(08)60108-7.Search in Google Scholar
5. Meis, P, Klebanoff, M, Thom, E. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 2003;348:2379–85. https://doi.org/10.1056/nejmoa035140.Search in Google Scholar
6. Da Fonseca, E, Bittar, R, Carvalho, M, Zugaib, M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol 2003;188:419–24. https://doi.org/10.1067/mob.2003.41.Search in Google Scholar
7. Fonseca, E, Celik, E, Parra, M, Singh, M, Nicolaides, K. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007;357:462–9. https://doi.org/10.1056/nejmoa067815.Search in Google Scholar
8. Norman, J, Marlow, N, Messow, C, Shennan, A, Bennett, P, Thornton, S. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet 2016;387:2106–16. https://doi.org/10.1016/s0140-6736(16)00350-0.Search in Google Scholar
9. Romero, R, Conde-Agudelo, A, El-Refaie, W, Rode, L, Brizot, ML, Cetingoz, E, et al.. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol 2017;49:303–14. https://doi.org/10.1002/uog.17397.Search in Google Scholar PubMed PubMed Central
10. Serra, V, Perales, A, Meseguer, J, Parrilla, J, Lara, C, Bellver, J, et al.. Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomized controlled double-blind multicenter trial. Br J Obstet Gynaecol 2012;120:50–7. https://doi.org/10.1111/j.1471-0528.2012.03448.x.Search in Google Scholar PubMed
11. Shaaban, OM, Hassanin, IM, Makhlouf, AM, Salem, MN, Hussein, M, Mohamed, M, et al.. Vaginal progesterone for prevention of preterm delivery inwomen with twin pregnancy: a randomized controlled trial. Facts Views Vis Obgyn 2018;10:93–8.Search in Google Scholar
12. Klein, K, Rode, L, Nicolaides, KH, Krampl-Bettelheim, E, Tabor, A. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol 2011;38:281–7. https://doi.org/10.1002/uog.9092.Search in Google Scholar PubMed
13. Romero, R, Nicolaides, K, Conde-Agudelo, A, Tabor, A, O’brien, JM, Cetingoz, E, et al.. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the mid-trimester decreases preterm delivery and neonatal morbidity: a systematic review and meta-analysis of individual patient data. Am J Obstet Gynecol 2012;206:124.e1–19. https://doi.org/10.1016/j.ajog.2011.12.003.Search in Google Scholar PubMed PubMed Central
14. Schuit, E, Stock, S, Rode, L, Rouse, DJ, Lim, AC, Norman, JE, et al.. Global Obstetrics Network (GONet) collaboration. Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. Br J Obstet Gynaecol 2015;122:27–37. https://doi.org/10.1111/1471-0528.13032.Search in Google Scholar PubMed PubMed Central
15. El-refaie, W, Abdelhafez, MS, Badawy, A. Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety. Arch Gynecol Obstet 2016;293:61–7. https://doi.org/10.1007/s00404-015-3767-1.Search in Google Scholar PubMed
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Articles in the same Issue
- Frontmatter
- Corner of Academy
- Cost of providing cell-free DNA screening for Down syndrome in Finland using different strategies
- Adverse perinatal outcomes following the prenatal diagnosis of isolated single umbilical artery in singleton pregnancies: a systematic review and meta-analysis
- Original Articles – Obstetrics
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- Original Articles – Fetus
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- Comment on Abdel Wahab et al.: A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations
- Re: Comment on Abdel Wahab et al.: A randomized controlled trial of two-doses of vaginal progesterone 400 vs. 200 mg for prevention of preterm labor in twin gestations
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