TY - JOUR
T1 - Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol
AU - Goudar, Shivaprasad S.
AU - Chakraborty, Hrishikesh
AU - Edlavitch, Stanley A.
AU - Naik, Vijaya A.
AU - Bellad, M. B.
AU - Patted, Shobhana S.
AU - Patel, Ashlesha
AU - Moore, Janet
AU - McClure, Elizabeth M.
AU - Hartwell, Tyler
AU - Moss, Nancy
AU - Derman, Richard J.
AU - Kodkany, Bhalchandra S.
AU - Geller, Stacie E.
N1 - Funding Information:
The trial was conducted under the auspices of the Global Network for Women’s and Children’s Health Research, a multi-site research network supported by the U.S. National Institutes of Health. Prior to initiation of the study, approval was obtained from the relevant institutional review boards: Jawaharlal
Funding Information:
Funding for the project was provided by the National Institute of Child Health and Human Development Grant # 1 U01 HD42372-01, ‘UIC-UMKC-JNMC Women’s and Children’s Research Unit’ and by a grant from the Bill and Melinda Gates Foundation.
PY - 2008
Y1 - 2008
N2 - Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss ≥500mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n=808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. Results. As the study duration increased, the duration of the second stage of labor decreased (-0.12, p=0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. Conclusions. Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial.
AB - Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss ≥500mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n=808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. Results. As the study duration increased, the duration of the second stage of labor decreased (-0.12, p=0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. Conclusions. Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial.
KW - Misoprostol
KW - PPH
KW - Postpartum hemorrhage
KW - Provider skills
KW - Training monitoring
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U2 - 10.1080/14767050802132158
DO - 10.1080/14767050802132158
M3 - Article
C2 - 18609354
AN - SCOPUS:49749118699
SN - 1476-7058
VL - 21
SP - 559
EP - 564
JO - Journal of Maternal-Fetal and Neonatal Medicine
JF - Journal of Maternal-Fetal and Neonatal Medicine
IS - 8
ER -