Published: 2019-04-23

Evaluation of clinical efficacy and safety of natural micronized progesterone in prevention of preterm labor: a prospective study at tertiary care teaching hospital in India

Suhani V. Patel, Shahnoor K. Gowani, Sushma R. Shah, Supriya D. Malhotra


Background: Uterine relaxants (UR) are used in management of in Preterm labour (PTL), which is responsible for considerable morbidity and mortality in mother as well as preterm infant. Author are yet to discover an ideal UR which is highly effective yet safe. Literature supports the use of natural micronized progesterone (NP) during threatened PTL. However, little data exists for Indian population. Therefore, present study becomes imperative.

Methods: A comparative clinical study was carried out on 78 patients (aged 19 to 35 years with singleton pregnancy and gestational age between 28 and 37 weeks with cervix ≤4 cm dilated) who were diagnosed with threatened PTL were included. Those who refused treatment were allocated to control group (n= 29) and received only bed rest. NP was given orally 200 mg twice a day to 21 patients and 200 mg intra vaginal twice a day to 28 patients and was continued until delivery or 37 weeks of gestation whichever occurred first. The efficacy was proven if PTL was prevented and patient did not require an alternative UR for ≥48 hours.

Results: The mean age of patients was 23±3.2 years, majority being multipara. Author observed that both oral and vaginal formulation of NP was found to be highly effective (p <0.05) as primary UR and maintenance therapy in preventing PTL as compared to the control group. However, difference between them was not statistically significant. None of the patients were lost to follow-up and no adverse events linked to the treatment were reported.

Conclusions: Although, the data obtained from this study was limited and the sample size was small, findings of this study support the use of NP in prolonging threatened PTL.


Preterm labour, Progesterone in preterm labour, Tocolytics

Full Text:



Quinn JA, Munoz FM, Gonik B, Frau L, Cutland C, Mallett-Moore T, et al. Preterm birth: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2016;34(49):6047-56.

WHO. Preterm birth, 2017. Available at: 1 March 2019.

Luu TM, Rehman Mian MO, Nuyt AM. Long-Term Impact of Preterm Birth: Neurodevelopmental and Physical Health Outcomes. Clin Perinatol. 2017;44(2):305-14.

Tabassum S, Shahzadi U, Khalid A. Comparative study of efficacy of magnesium sulfate and nifedipine in suppression of preterm labour. PJMHS. 2016;10(4):1307.

Yasmin S, Sabir S, Zahoor F. To compare the effectiveness of nifedipine and glyceryl trinitrate patch in prevention of preterm labour. J Postgrad Med Inst. 2016;30(1):92-6.

Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Australian New Zealand J Obs Gynaecol. 2008;48:58-63.

Kauppila A, Hartikainen-Sorri AL, Jänne O, Tuimala R, Järvinen PA. Suppression of threatened premature labor by administration of cortisol and 17 alpha-hydroxyprogesterone caproate: a comparison with ritodrine. Am J Obstet Gynecol. 1980;138(4):404-8.

Erny R, Pigne A, Prouvost C, Gamerre M, Malet C, Serment H, et al. The potential tocolytic effect of natural progesterone administration on premature. Am J Obstet Gynecol 1986;154:525-9.

Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73.

Da Fonseca EB, Bittar RE, Carvalho MH, 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.

Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomized controlled trial. Aust NZJ Obstet Gynaecol. 2008;48:58-63.

Fonseca EB, Celik E, Parra M, Singh M. Nicolaides KH: Progesterone and the risk of preterm birth among women with a short cervix. Fetal Medicine Foundation Second Trimester Screening Group. N Engl J Med. 2007;357:462-9.