Oral Clindamycin for Prevention of Preterm Labor in Pregnancies of 13 to 16±1 Weeks with Vaginal Ph = 5 – A Randomized Double Blind Placebo Controlled Trial

Abstract

Introduction: Inspite of considerable advances, preterm labour (PTL) continues to be a major cause of perinatal and neonatal morbidity and mortality. Infection is responsible for 40 to 60%. Earlier the infection earlier the PTL. The present study is an attempt to prevent preterm labor with clindamycin in pregnant women with infection as evident by increased pH (≥ 5) Objective: Efficacy of Oral Clindamycin in prevention of PTL in pregnant women wit h vaginal pH ≥ 5 Study design: A randomized double blind placebo controlled trial. Study place: Teaching hospital attached to Jawaharlal Nehru Medical College, Belgaum Source of data: All the pregnant women meeting the selection criteria between 13 to 16 ± 1 weeks of gestation with vaginal pH>5. Study interventions: After screening pregnant women with infection (pH > 5) were randomized to either Oral Clindamycin (300 mg of Clindamycin) twice daily for five days) or Placebo capsules. These women were followed up for the pregnancy outcome. Analysis: χ2 test Results: Of the 836 screened 520 were consented to participate in the trial of which 210 had vaginal pH of > 5. These 210 women were randomly assigned to either clindamycin (110) or placebo group (100). The outcome was available for 198 women three women were excluded (twins). Pregnancy outcome of 195 IX women (100 in clindamycin and 95 in Placebo arm). The incidence of spontaneous PTL was significantly less in Clindamycin group (5% Vs 13.68%; p= 0.029). Similarly, the numbers of low birth weight babies were fewer in clindamycin group this was statistically significant (p-0.043). The late miscarriages in the present study were less in the clindamycin group however; this was statistically not significant (p-0.66). Conclusion: Oral Clindamycin significantly reduced the incidence of spontaneous PTL and low birth weight without any side effects.