Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol

Shivaprasad S. Goudar; Hrishikesh Chakraborty; Stanley A. Edlavitch; Vijaya A. Naik; M. B. Bellad; Shobhana S. Patted; Ashlesha Patel; Janet Moore; Elizabeth M. McClure; Tyler Hartwell; Nancy Moss; Richard J. Derman; Bhalchandra S. Kodkany; Stacie E. Geller

doi:10.1080/14767050802132158

Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol

Shivaprasad S. Goudar, Hrishikesh Chakraborty, Stanley A. Edlavitch, Vijaya A. Naik, M. B. Bellad, Shobhana S. Patted, Ashlesha Patel, Janet Moore, Elizabeth M. McClure, Tyler Hartwell, Nancy Moss, Richard J. Derman, Bhalchandra S. Kodkany, Stacie E. Geller

Obstetrics and Gynecology

Research output: Contribution to journal › Article › peer-review

15 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	559-564
Number of pages	6
Journal	Journal of Maternal-Fetal and Neonatal Medicine
Volume	21
Issue number	8
DOIs	https://doi.org/10.1080/14767050802132158
State	Published - 2008

Funding

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 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.

Keywords

Misoprostol
PPH
Postpartum hemorrhage
Provider skills
Training monitoring

ASJC Scopus subject areas

Obstetrics and Gynecology
Pediatrics, Perinatology, and Child Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1080/14767050802132158

Cite this

Goudar, S. S., Chakraborty, H., Edlavitch, S. A., Naik, V. A., Bellad, M. B., Patted, S. S., Patel, A., Moore, J., McClure, E. M., Hartwell, T., Moss, N., Derman, R. J., Kodkany, B. S., & Geller, S. E. (2008). Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol. Journal of Maternal-Fetal and Neonatal Medicine, 21(8), 559-564. https://doi.org/10.1080/14767050802132158

@article{c95557b4cc084901b3483eef0ebad1cb,

title = "Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol",

abstract = "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.",

keywords = "Misoprostol, PPH, Postpartum hemorrhage, Provider skills, Training monitoring",

author = "Goudar, {Shivaprasad S.} and Hrishikesh Chakraborty and Edlavitch, {Stanley A.} and Naik, {Vijaya A.} and Bellad, {M. B.} and Patted, {Shobhana S.} and Ashlesha Patel and Janet Moore and McClure, {Elizabeth M.} and Tyler Hartwell and Nancy Moss and Derman, {Richard J.} and Kodkany, {Bhalchandra S.} and Geller, {Stacie E.}",

note = "Funding Information: The trial was conducted under the auspices of the Global Network for Women{\textquoteright}s and Children{\textquoteright}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, {\textquoteleft}UIC-UMKC-JNMC Women{\textquoteright}s and Children{\textquoteright}s Research Unit{\textquoteright} and by a grant from the Bill and Melinda Gates Foundation.",

year = "2008",

doi = "10.1080/14767050802132158",

language = "English (US)",

volume = "21",

pages = "559--564",

journal = "Journal of Maternal-Fetal and Neonatal Medicine",

issn = "1476-7058",

publisher = "Informa Healthcare",

number = "8",

}

Goudar, SS, Chakraborty, H, Edlavitch, SA, Naik, VA, Bellad, MB, Patted, SS, Patel, A, Moore, J, McClure, EM, Hartwell, T, Moss, N, Derman, RJ, Kodkany, BS & Geller, SE 2008, 'Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol', Journal of Maternal-Fetal and Neonatal Medicine, vol. 21, no. 8, pp. 559-564. https://doi.org/10.1080/14767050802132158

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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ER -

Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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