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Prophylactic administration of clindamycin 2% vaginal cream to reduce the incidence of spontaneous preterm birth in women with an increased recurrence risk: a randomised placebo-controlled double-blind trial.
Br J Obstet Gynaecol. 1999 Jul; 106(7):652-7.BJ

Abstract

OBJECTIVE

To test the hypothesis that prophylactic administration of clindamycin 2% vaginal cream can reduce the incidence of preterm birth in a high risk population.

DESIGN

A multi-centre, randomised, double-blind, placebo-controlled trial.

SETTING

Twelve city hospitals in The Netherlands.

PARTICIPANTS

One hundred and sixty-eight women with a singleton pregnancy and a history of a spontaneous preterm delivery in the preceding pregnancy.

INTERVENTIONS

Clindamycin 2% vaginal cream, or placebo cream, administered daily for seven days at 26 and 32 weeks of gestation.

MAIN OUTCOME MEASURES

Spontaneous preterm birth at < 37 weeks, admission for threatened preterm labour, neonatal infectious morbidity.

RESULTS

In the intention-to-treat analysis no difference was found in overall preterm birth between clindamycin and placebo (23% vs 18%, respectively). In the subgroup who completed the trial and administered all medication, more women delivered before 34 weeks in the clindamycin group (1.4% in the placebo vs 9.0% in the clindamycin group; P < 0.05). The length of admissions for threatened preterm labour did not differ. More infectious neonatal morbidity was seen in the clindamycin group (5/83 vs 0/85; P < 0.05).

CONCLUSION

Clindamycin 2% vaginal cream given prophylactically to women with a spontaneous preterm birth in the preceding pregnancy did not prevent preterm delivery or reduce the number of admissions for threatened preterm labour. The neonatal infectious morbidity in the group treated with clindamycin was significantly higher and a major concern.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Diaconessenhuis Meppel, The Netherlands.No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10428520

Citation

Vermeulen, G M., and H W. Bruinse. "Prophylactic Administration of Clindamycin 2% Vaginal Cream to Reduce the Incidence of Spontaneous Preterm Birth in Women With an Increased Recurrence Risk: a Randomised Placebo-controlled Double-blind Trial." British Journal of Obstetrics and Gynaecology, vol. 106, no. 7, 1999, pp. 652-7.
Vermeulen GM, Bruinse HW. Prophylactic administration of clindamycin 2% vaginal cream to reduce the incidence of spontaneous preterm birth in women with an increased recurrence risk: a randomised placebo-controlled double-blind trial. Br J Obstet Gynaecol. 1999;106(7):652-7.
Vermeulen, G. M., & Bruinse, H. W. (1999). Prophylactic administration of clindamycin 2% vaginal cream to reduce the incidence of spontaneous preterm birth in women with an increased recurrence risk: a randomised placebo-controlled double-blind trial. British Journal of Obstetrics and Gynaecology, 106(7), 652-7.
Vermeulen GM, Bruinse HW. Prophylactic Administration of Clindamycin 2% Vaginal Cream to Reduce the Incidence of Spontaneous Preterm Birth in Women With an Increased Recurrence Risk: a Randomised Placebo-controlled Double-blind Trial. Br J Obstet Gynaecol. 1999;106(7):652-7. PubMed PMID: 10428520.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prophylactic administration of clindamycin 2% vaginal cream to reduce the incidence of spontaneous preterm birth in women with an increased recurrence risk: a randomised placebo-controlled double-blind trial. AU - Vermeulen,G M, AU - Bruinse,H W, PY - 1999/7/31/pubmed PY - 2000/6/10/medline PY - 1999/7/31/entrez KW - Antibiotics KW - Demographic Factors KW - Developed Countries KW - Double-blind Studies KW - Drugs KW - Europe KW - Netherlands KW - Population KW - Population Characteristics KW - Pregnancy KW - Pregnancy Outcomes KW - Pregnant Women KW - Premature Birth--prevention and control KW - Reproduction KW - Research Methodology KW - Research Report KW - Studies KW - Treatment KW - Western Europe SP - 652 EP - 7 JF - British journal of obstetrics and gynaecology JO - Br J Obstet Gynaecol VL - 106 IS - 7 N2 - OBJECTIVE: To test the hypothesis that prophylactic administration of clindamycin 2% vaginal cream can reduce the incidence of preterm birth in a high risk population. DESIGN: A multi-centre, randomised, double-blind, placebo-controlled trial. SETTING: Twelve city hospitals in The Netherlands. PARTICIPANTS: One hundred and sixty-eight women with a singleton pregnancy and a history of a spontaneous preterm delivery in the preceding pregnancy. INTERVENTIONS: Clindamycin 2% vaginal cream, or placebo cream, administered daily for seven days at 26 and 32 weeks of gestation. MAIN OUTCOME MEASURES: Spontaneous preterm birth at < 37 weeks, admission for threatened preterm labour, neonatal infectious morbidity. RESULTS: In the intention-to-treat analysis no difference was found in overall preterm birth between clindamycin and placebo (23% vs 18%, respectively). In the subgroup who completed the trial and administered all medication, more women delivered before 34 weeks in the clindamycin group (1.4% in the placebo vs 9.0% in the clindamycin group; P < 0.05). The length of admissions for threatened preterm labour did not differ. More infectious neonatal morbidity was seen in the clindamycin group (5/83 vs 0/85; P < 0.05). CONCLUSION: Clindamycin 2% vaginal cream given prophylactically to women with a spontaneous preterm birth in the preceding pregnancy did not prevent preterm delivery or reduce the number of admissions for threatened preterm labour. The neonatal infectious morbidity in the group treated with clindamycin was significantly higher and a major concern. SN - 0306-5456 UR - https://www.unboundmedicine.com/medline/citation/10428520/Prophylactic_administration_of_clindamycin_2_vaginal_cream_to_reduce_the_incidence_of_spontaneous_preterm_birth_in_women_with_an_increased_recurrence_risk:_a_randomised_placebo_controlled_double_blind_trial_ L2 - https://medlineplus.gov/pretermlabor.html DB - PRIME DP - Unbound Medicine ER -