Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
The purpose of this study is to determine efficacy of vaginal and oral progesterone after
 tocolytic therapy in threatened preterm labor
A randomized controlled trial was conducted from August 2015 through December 2016. All
 pregnant women with single pregnancies of 28 to 33 weeks and 6 days who had been experienced
 for threatened or preterm labor with intact membrane as in inclusion criteria were approached
 and ask for enrollment. The gestational age of all patients was confirmed by antenatal record
 review and ultrasonographic confirmation. Threatened preterm labor was defined as the
 presence of regular uterine contractions without significant cervical changes as determined
 by digital pelvic examination. Preterm labor was defined as the simultaneous presence of
 regular uterine contractions and cervical changes, shortening and/or softening, or
 dilatation, as determined by digital pelvic examination. The women with preterm labor
 underwent standard tocolysis, which was administered for at least 48 hours, to allow
 corticosteroid promote fetal lung maturation. The patients who had proven membranes ruptured,
 and ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly or
 aneuploidy would excluded. The participants had emergency condition that required for
 emergency delivery such as fetal distress, chorioamnionitis were also excluded. Participants
 were randomized into three groups which generated by computer programme to receive whether
 oral progesterone (dydrogesterone 10 mg; Duphaston™) per oral three times a day or vaginal
 progesterone (micronized progesterone 200 mg; Utrogestan™) or no progesterone (controlled
 group). All patients were digitally pelvic examined for evaluation of Bishop score and
 assessed cervical length by transvaginal ultrasound at enrollment and follow up visit at two
 weeks apart. Cervical length was measured by standard technique with a covered probe inserted
 into vagina after each woman had emptied her bladder. Excessive pressure on cervix was
 avoided. The mean value of 3 consecutive measurements was used for analysis. Informed consent
 and demographic data were obtained at the enrollment. Primary outcomes were preterm delivery
 before 34 and 37 weeks. Secondary outcomes include time until delivery (latency period,days),
 change of cervical length (cervical attenuation), maternal outcome, neonatal outcome, and
 side effects of drugs were collected. The main outcomes of preterm delivery, gestational age
 at parturition and birthweight were also collected by telephone call in case of
 out-side-hospital born or in case loss to follow up. Monitoring of all patients was evaluated
 every follow up visit for drug side effect, allergic response, and adverse events Statistical
 analysis Sample size was calculated according to the results of two studies by Dorota
 AgataBomba - Opon and Manju Choudhary which showed significant decreased preterm delivery <34
 weeks (9.8% vs 35.3%,p=0.002) in vaginal progesterone group, and significant decreased
 preterm birth (33% vs 58% ; p= 0.034) in oral progesterone group. The sample size of 231 was
 used to evaluate the primary outcome of both drugs. Descriptive statistics were carried out
 using mean, median, standard deviation, interquartile range. Categorical data were tested for
 significance with the χ2tests. Continuous data were evaluated for normal distribution and
 tested for significance with ANOVA and Kruskal-Wallis test. Student t test and Man-Whitney U
 test were used to test significance between groups in case there is significant detection in
 ANOVA and Kruskal-Wallis test among groups. Statistical significance was defined as p<0.05.
Inclusion Criteria:

 -  Single pregnancies of 28 to 33 weeks and 6 days who had been experienced for
 threatened or preterm labor with intact membrane

 Exclusion Criteria:

 -  Proven membranes ruptured

 -  Ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly

 -  Aneuploidy detected.

 -  Had emergency condition that required for emergency delivery such as fetal distress,
 chorioamnionitis, prolapsed cord