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

Abstract

Objective: 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.

Efficacy of intramuscular progesterone in prevention of preterm birth in patients with history of preterm birth

“…predisposition, Afiro-American lineage, short cervical length, twin pregnancy, infectious diseases, smoking, uterine anomaly, previous curettage or cervical coning. [1][2][3][4][5][6][7][8] Many drugs are used to prevent preterm deliveries which include tocolytics, antibiotics and steroids. The role of progesterone in prevention of preterm deliveries was first identified in 1954.…”

“…Studies have shown that progesterone have no role in preventing preterm deliveries in patients with twin pregnancies, so here it is not recommended. 2,[5][6][7][8][9] So the aim of the current study was to determine the frequency of preterm birth in patients treated with oral versus intramuscular progesterone in patients having history of previous preterm birth in our population. So that maternal and fetal morbidity and mortality can be reduced.…”