A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor

Abstract

The primary aim of this study was to evaluate the effect of oral dydrogesterone on the recurrent uterine contraction in preterm labor. The secondary aims were to evaluate latency period, gestational age at delivery, pregnancy outcomes, neonatal outcomes, compliance and side effects. A randomized, double blinded, placebo controlled trial was conducted. Forty-eight pregnant women at 24–34 weeks gestation with preterm labor were either randomized to study group receiving tocolytic treatment combined with oral dydrogesterone (20 mg daily) or to placebo group receiving tocolytic treatment combined with oral placebo. Recurrent rates of uterine contraction were comparable between groups (87.5% vs 91.7%, p = 0.64). Latency periods were not different between dydrogesterone and placebo group (32.7 ± 20.2 days vs 38.2 ± 24.2 days, p = 0.39). There were also no differences in gestational age at delivery, pregnancy outcomes, neonatal outcomes, compliance and side effects. Adjuvant treatment with oral dydrogesterone 20 mg/day could not decrease the rates of recurrent uterine contraction and prolong latency period in preterm labor management when compared to placebo.

The value of oral micronized progesterone in the prevention of recurrent spontaneous preterm birth: a randomized controlled trial

“…Traditionally, the bioavailability of orally administered progesterone was questionable, due to hepatic first‐pass metabolism . This may at least partly explain why dydrogesterone, a synthetic oral progesterone, was recently found ineffective in preventing SPD . However, micronization increases the bioavailability of oral progesterone to the point where serum therapeutic levels may be attained .…”

Oral Versus Vaginal Progesterone In Preterm Labor

“…In the opposite side Wilasinee et al, 2016, found that the rate of uterine contractions and the interval till delivery were indifferent between the dydrogesterone and placebo groups. Also the fetal maturity at delivery, perinatal outcomes, compliance and side effects were almost the same [24] . We could explain such conflict with our results by; first, the time of onset, duration and dose of the progesterone used, second, different sample size and third, different population and demographics and fourth the different risk factors they included in their work.…”

Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial

“…or over 35 years is the risk factor for PTB [14]. Some authors compare progesterone supplementation versus no intervention [15] [16]. The ethics committee of our institution refused to make group C with no intervention.…”

“…Moreover, it can also be used for secondary prevention after tocolysis in singleton pregnancy [21]. Oral dedrogesterone was ineffective in a randomized controlled trial [16]. In this study, we used oral micronized natural progesterone for group A in dose of 200 mg daily.…”