Progesterone for maintenance tocolytic therapy after threatened preterm labour: A randomised controlled trial

Abstract

Background: Women with preterm labour that is arrested with tocolytic therapy are at increased risk of recurrent preterm labour. The efficacy of maintenance tocolytic therapy after successful arrest of preterm labour remains controversial. Aim: The purpose of this study was to determine whether supplementation of vaginal progesterone after inhibition of preterm labour is associated with an increased latency period and a decreased recurrent of preterm labour. Methods: This trial was conducted in 70 women who presented with symptoms of threatened preterm labour, who after arrest of uterine activity were then randomised to progesterone therapy or no treatment. Treatment group received progesterone suppository (400 mg) daily until delivery and control group received no treatment. Results: Longer mean latency until delivery (36/11 ± 17/9 vs 24/52 ± 27/2) (mean + standard deviation) days; respiratory distress syndrome 4 (10.8%) vs 12 (36.4%) P = 0.021; low birthweight 10 (27%) vs 17 (51.5%) P = 0.04; and birthweight (3101.54 ± 587.9 g vs r 2609.39 ± 662.9 g, P = 0.002), were significantly different between the two groups.No significant differences were found between recurrent preterm labour 13 (35.1%) vs 19 (57.6%), P = 0.092; admission to intensive care unit 9 (24.3%) vs 13 (39.4%), P = 0.205 ; and neonatal sepsis 2 (5.4%) vs 6 (18.2%) P = 0.136, for the progesterone and control groups, respectively. Conclusion: The use of vaginal progesterone suppository after successful parenteral tocolysis associated with a longer latency preceding delivery but failed to reduce the incidence of readmission for preterm labour.

Progesterone and preterm birth prevention: translating clinical trials data into clinical practice

“…(65) In summary, there is currently insufficient evidence to recommend progesterone primarily for, or as an adjunct to, tocolysis.…”

Comparative Study to Assess the Efficacy Between Intramuscular and Vaginal Micronized Progesterone to Prevent Threatened Premature Labour

“…[19][20][21][22][23][24][25][26][27][28][29][30] But there are few studies regarding role of progesterone in threatened PTL. [34][35][36][37][38][39] Most of the studies compared the effect of progesterone as a maintainance tocolytic with placebo after initial tocolysis with other agents. There are very few studies compairing the different routes of use of progeterone.…”

The role of micronized progesterone in preterm labour

“…In various studies improvement in birth weight ranged from 290-490 gms. 11,[13][14][15]18 NICU admission were also less in study group(14% vs 24%) with shorter nursery stay(7.71 vs 8.41 days).Neonatal complications like RDS, sepsis, mechanical ventilation were also less in study group. There was one case of neonatal death in Group II.…”

“…10 Women who have had an episode of preterm labour arrested by tocolysis comprise a group at especially high risk for preterm delivery. 11 Progesterone has not been extensively studied in this population. Natural progesterone is free of any disturbing teratogenic, metabolic or hemodynamic effects.…”

“…Results are similar as reported in literature though progesterone, dose and route are different in various studies. 11,[13][14][15][16] Borna et al reported difference in prolongation of pregnancy by 11.5 days while Gargari et al reported it to be 2.6 weeks. Bomba-Opon et al observed a significant reduction in delivery before 34 weeks with vaginal progesterone (9.8% in progesterone group versus 35.3% in control group; p = 0.002).…”