Endometritis — Antibiotic Prophylaxis in Ragged Placental Membranes
Citation(s)
Chibueze EC, Parsons AJ, Ota E, Swa T, Oladapo OT, Mori R Prophylactic antibiotics for manual removal of retained placenta during vaginal birth: a systematic review of observational studies and meta-analysis. BMC Pregnancy Childbirth. 2015 Nov 26;15:313. doi: 10.1186/s12884-015-0752-4. Review.
Chongsomchai C, Lumbiganon P, Laopaiboon M Prophylactic antibiotics for manual removal of retained placenta in vaginal birth. Cochrane Database Syst Rev. 2014 Oct 20;(10):CD004904. doi: 10.1002/14651858.CD004904.pub3. Review.
Meaney-Delman D, Bartlett LA, Gravett MG, Jamieson DJ Oral and intramuscular treatment options for early postpartum endometritis in low-resource settings: a systematic review. Obstet Gynecol. 2015 Apr;125(4):789-800. doi: 10.1097/AOG.0000000000000732. Review. Erratum in: Obstet Gynecol. 2015 Aug;126(2):452-3.
Newton ER, Prihoda TJ, Gibbs RS A clinical and microbiologic analysis of risk factors for puerperal endometritis. Obstet Gynecol. 1990 Mar;75(3 Pt 1):402-6.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
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