TITLE:
Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial
AUTHORS:
Atef M. M. Darwish, Alaa E. M. Ismail, Maher S. Mohammad, Salah A. E. Gobara
KEYWORDS:
Preterm Birth, Oral, Injectable, Progesterone, Health Education
JOURNAL NAME:
Open Journal of Obstetrics and Gynecology,
Vol.9 No.5,
May
14,
2019
ABSTRACT: The primary aim of this study was to evaluate the possible prophylactic
role of progesterone in women with a history of spontaneous preterm birth (PTB) while the secondary
aim was to compare
oral or intramuscular
progesterone versus health education in such cases. Methods: A randomized, single blinded interventional
randomized controlled trial was conducted. It comprised 90 cases with a history
of PTB who were divided into 3 equal groups who received oral micronized
progestogen capsule 200 mg daily (group A), parenteral 17 α-hydroxyprogesterone caproate 250 mg weekly IM injections (group B) or
received health education including rest (group C) starting from 20 weeks till
the end of 34 weeks of gestation. Results: This study included eligible 90 pregnant women at high risk of PTB who continued follow-up.
For socio-demographic characteristics, there were no significant differences
between the groups in respect to age, residence, education level, occupation,
gravidity, parity and number of living children apart from significant
difference between group A and C regarding mean patients’ age. Mode and place of delivery
did not differ between the groups while gestational age at time of delivery was
significantly better on using injectable than oral progesterone. Neonatal birth
weight was significantly higher in group B if compared separately to groups A
and C and was still significantly higher in group A if compared with group C.
NICU admission rate was higher in group C if compared to group B or to the combined
group A and B. Compliance was significantly higher in group B if compared to
both group A and C and was significantly higher in the intervention group A and
B if compared to group C. Conclusions: Progesterone supplementation has a significant role in prevention of PTB
if compared with just health education. Progesterone injections expressed significantly
better results than oral micronized progesterone in terms of prolongation of
gestational age, better neonatal birth weight and less admission rate to the
NICUs.