title: Intravaginal use of natural micronised progesterone to prevent pre-term birth: a randomised trial in India.
abstract: In a prospective, randomised trial, 100 pregnant women with >/= one prior spontaneous pre-term birth were randomised into two groups. Group 1 women received 100 mg natural micronised progesterone intravaginally once daily from 20-24 weeks' gestation until 36 weeks. Group 2 women did not receive progesterone. Both groups were regularly supervised until delivery. Pre-term birth (<37 and <34 weeks) and other maternal, neonatal outcomes were primary and secondary outcomes, respectively. Chi-square test and Fisher exact test were used to compare categorical variables. Independent sample t-test and one-way ANOVA were used to compare continuous variables and multiple comparisons, respectively. Pre-term births <37 weeks were significantly lower in Group 1 (12% vs 38%, p = 0.002), but pre-term births <34 weeks were similar. The mean birth weight of neonates born to women in Group 1 was significantly higher (2800 vs 2,500 g, p = 0.023). We concluded intravaginal administration of 100 mg of natural micronised progesterone significantly reduced the incidence of pre-term birth <37 weeks in women with > or = one prior pre-term birth. Future research is warranted to assess the long-term safety and efficacy of progesterone.
authors.affiliation: Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Vellore, Tamilnadu 632004, India. pratimahere@gmail.com
authors.forename: P
authors.initials: P
authors.lastname: Majhi
authors.forename: R
authors.initials: R
authors.lastname: Bagga
authors.forename: J
authors.initials: J
authors.lastname: Kalra
authors.forename: M
authors.initials: M
authors.lastname: Sharma
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D005260:Female; D006801:Humans; D007194:India; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D011374:Progesterone / Q000008:administration & dosage*; D011372:Progestins / Q000008:administration & dosage*; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D011372:Progestins; D011374:Progesterone