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\begin{document}


\def\RunningAuthor{Hemalatha S et al.}
\firstPage{4625}
\articleType{Original Article}
\receivedDate{05 Apr 2020}
\acceptedDate{07 May 2020}
\revisedDate{18 Apr 2020}
\journalVolume{2020, 11}
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\title{Evaluate the Potency of Misoprostol for Management of Postpartum Hemorrhage in Maternal Women}
\author{Shaheedha~S~M\textsuperscript{1},  
            Hemalatha~S\textsuperscript{*}\textsuperscript{2}, 
            Ramakrishna~Borra\textsuperscript{3}~\\[5pt]{\textsuperscript{1}Crescent School of Pharmacy, B.S.Abdur Rahman Crescent Institute of Science and Technology, Seethakathi estate, GST Road, Vandalur, Chennai 600048, Tamilnadu, India}~\\{\textsuperscript{2}Tagore College of Pharmacy, Rathinamangalam, Chennai 600127, Tamilnadu, India}~\\{\textsuperscript{3}Sri Venkateswara College of Pharmacy, RVS Nagar, Tirupathi Road, Chittoor, Andhra Pradesh, India}}

\begin{abstract}
The present study to investigate the extent of use of misoprostol in postpartum hemorrhage. To evaluate the knowledge of prevention and treatment of managing PPH among health care providers. To educate the pregnant women and midwives on the treatment approaches for PPH. The present study was conducted in RVS Institute of Medical Sciences, Chittoor, Andhra Pradesh. The materials required for the study are collected from the gynecology and obstetrics department of the hospital included in the study. The study details with all the details of aim, objective, methodology, inclusion criteria, exclusion criteria, expected outcome have been submitted to the ethical committee, and after getting a positive opinion from the institution ethics committee(IEC) towards the study, the work has been started.  The study included about 316 maternal women. All the women included in the study have been administered with Misoprostol after giving birth to the neonate to prevent the occurrence of atonic PPH, which is the most widely seen complication resulting in birth of maternal women. The common side effects observed in the maternal women were vomiting, which was reported in 27 women out of 316 women. Diarrhea was reported in 12 women out of all study population. Shivering was accounted in 167 women, thus, shivering is the major side effect noted with administration of misoprostol. One women was reported with an elevated diastolic blood pressure of {\textgreater}100 mm of Hg out of 316 women. Manual removal of placenta was necessitated in 19 women. Misoprostol was administered in all the women (n = 316) after 4- 5 hours of delivery. However, it's needed to increase the mandatory guidelines for management of various complications accounted during delivery to prevent maternal mortality rate.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Misoprostol,\newline Postpartum hemorrhage,\newline Maternal women,\newline Postnatal ward
\end{keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Hemalatha~S~\\ Phone:\ +91- 7200345257~\\  Email:\ kavyasahana21@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
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\section{Introduction}
Postpartum hemorrhage (PPH) is a condition in which the failure of the uterus to contract adequately after childbirth, which is known as uterine atony is not adequate \unskip~\citep{828118:19796019}. This results in a condition called postpartum hemorrhage, which very commonly involves heavy blood loss\unskip~\citep{828118:19796020}. Thus, World Health Organization has reported that one third maternal deaths occurred world wide have been accounted from PPH. About 99\% of maternal deaths are reported from poor countries and undeveloped countries\unskip~\citep{828118:19796030}. PPH is the third dangerous stage of a maternal mother which may result in death\unskip~\citep{828118:19796028}. Atonic PPH accounts for about 90\% of PPH's during delivery of baby \unskip~\citep{828118:19796036}. Other causes of PPH includes blood transfusion, renal failure, anemia and coagulation deficiencies, trauma in genital tract (traumatic PPH), retention of placental tissue and failure of coagulation system\unskip~\citep{828118:19796032}. If the blood loss from the genital tract is measured above 500 mL or more in the first 24hours after the delivery of the baby, the condition is considered as postpartum hemorrhage (PPH)\unskip~\citep{828118:19796016}. Similarly, if the blood loss from the genital tract is measured to be equal to or greater than 1000 mL, then the condition is considered as severe postpartum hemorrhage (SPPH)\unskip~\citep{828118:19796025}. 

\textbf{Clinical management of PPH}

During the third stage of PPH, it can be managed clinically either by following hysterectomy or other surgical procedures to reduce the rate of blood flow \unskip~\citep{828118:19796021}. But, the major drawback of following a surgical procedure includes, consideration of fertility and the extent of burden of PPH should always be quantified before performing a surgery \unskip~\citep{828118:19796031}. Beyond surgery, therapeutic management of PPH includes injectable use of Oxytocin or ergotamine is considered \unskip~\citep{828118:19796035}. But, the major drawbacks of oxytocin and ergotamine includes critical storage conditions, due to their thermoliable properties \unskip~\citep{828118:19796016}. 

Misoprostol is the alternative choice of drug for treating PPH in any stage\unskip~\citep{828118:19796033}.  Misoprostol is a thermostable drug which can be used either orally or vaginally, which is also effective for inducing abortion and also for initiation of labor by making the uterus to contract, and for use in conditions of peptic ulcer disease caused by prostaglandin synthatase inhibitors\unskip~\citep{828118:19796034}. Misoprostol is a synthetic analogue of methyl ester of natural prostaglandin E1(14). Misoprostol exhibits good absorption properties, which shows its peak plasma concentrations within 30min after administering orally or sublingually \unskip~\citep{828118:19796027,828118:19796029}. 

\textbf{Aims and objectives}


  
  \begin{enumerate}
  \item \relax To investigate the extent of use of misoprostol in postpartum hemorrhage.
  \item \relax To evaluate the knowledge of prevention and treatment of managing PPH among health care providers.
  \item \relax To educate the pregnant women and midwives on the treatment approaches for PPH.
  \item \relax To investigate any additional need for administration of oxytocin is required in patients treated with misoprostol.
  \end{enumerate}
  
    
\section{Materials and Methods}

\begin{table*}[!htbp]
\caption{\boldmath {Various Demographic Parameters of Maternal Women} }
\label{tw-39c887e069b7}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.6853\linewidth-2\tabcolsep}p{\dimexpr.31469999999999995\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameters & Number of women or mean (SD) \mbox{}\protect\newline (Total, n = 316)\\
\tblmidrule 
\textbf{Demographic characteristics} &
  \\
Maternal age (years) \mbox{}\protect\newline Maternal weight (kg) \mbox{}\protect\newline Maternal height (cm) \mbox{}\protect\newline Primigravidae \mbox{}\protect\newline Gestational age at delivery (weeks) &
  27.8 (5.9) \mbox{}\protect\newline 79.4 (12.1) \mbox{}\protect\newline 165.1 (6.6) \mbox{}\protect\newline 145 (51) \mbox{}\protect\newline 38.9 (2.0)\\
\textbf{Labour variables} &
  \\
Spontaneous onset \mbox{}\protect\newline Augmentation of labor \mbox{}\protect\newline Epidural analgesia \mbox{}\protect\newline Narcotic analgesia \mbox{}\protect\newline Episiotomy \mbox{}\protect\newline First and second degree tear \mbox{}\protect\newline Instrumental vaginal delivery \mbox{}\protect\newline Length of 1st stage (h) \mbox{}\protect\newline Length of 2nd stage (min) \mbox{}\protect\newline Birth weight (kg) &
  210 (78) \mbox{}\protect\newline 91 (34) \mbox{}\protect\newline 176 (56) \mbox{}\protect\newline 92 (37) \mbox{}\protect\newline 43 (23) \mbox{}\protect\newline 123 (55) \mbox{}\protect\newline 75 (20) \mbox{}\protect\newline 6.6 (4.0) \mbox{}\protect\newline 69 (61) \mbox{}\protect\newline 3.15 (0.60)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Vitals Measured in Study Population before and after Delivery} }
\label{tw-74bf4d68fab6}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.2794\linewidth-2\tabcolsep}p{\dimexpr.13059999999999999\linewidth-2\tabcolsep}p{\dimexpr.16400000000000006\linewidth-2\tabcolsep}p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.14819999999999999\linewidth-2\tabcolsep}p{\dimexpr.1178\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Parameters & N & Before delivery & After delivery & Difference & P\\
\tblmidrule 
Systolic BP (mm of Hg) &
  316 &
  118.8  \mbox{}\protect\newline (12) &
  117.6 (12) &
  - 1.2 (0.9) &
  0.3\\
Diastolic blood pressure (mm of Hg) &
  316 &
  74.5  \mbox{}\protect\newline (7) &
  74.2  \mbox{}\protect\newline (11) &
  -0.3 (0.5) &
  0.21\\
Hemoglobin (g/dL) &
  112 &
  12.1 \mbox{}\protect\newline (1.1) &
  12.0 (1.2) &
  - 0.1 (0.13) &
  0.04\\
Haematocrit &
  118 &
  0.43 (0.03) &
  0.41 (0.04) &
  -0.02 (0.004) &
  0.045\\
Temperature ( \ensuremath{^\circ}C)  &
  219 &
  36.4 (0.4) &
  37.2 (0.8) &
  0.8 (0.06) &
  0.002\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Categorization and Incidence of PPH in Study Population} }
\label{tw-c916d454b9d2}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.6794\linewidth-2\tabcolsep}p{\dimexpr.32059999999999995\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Various parameters  & n = 316 (SD or \%)\\
\tblmidrule 
Blood loss \ensuremath{\leq } 500 mL \mbox{}\protect\newline Blood loss \ensuremath{\geq } 100 mL \mbox{}\protect\newline Blood loss (mL) \mbox{}\protect\newline Manual removal of placenta \mbox{}\protect\newline Required for other uterotonics like oxytocin and ergotamine. \mbox{}\protect\newline Systolic BP \ensuremath{\geq } 150 (mmHg) \mbox{}\protect\newline Diastolic BP \ensuremath{\geq } 100 (mmHg) \mbox{}\protect\newline Haemoglobin \textless\ 9 (g/dL) \mbox{}\protect\newline Third stage length (min) \mbox{}\protect\newline Third stage length \ensuremath{\geq } 30 min \mbox{}\protect\newline Vomiting \mbox{}\protect\newline Diarrhea \mbox{}\protect\newline Shivering &
  20 (6.32\%) \mbox{}\protect\newline 0 (0\%) \mbox{}\protect\newline 210 (160-300) \mbox{}\protect\newline 19 (6.01\%) \mbox{}\protect\newline 16 (5.06\%) \mbox{}\protect\newline 4 (1.26\%) \mbox{}\protect\newline 1(0.31\%) \mbox{}\protect\newline 12 (3.79\%) \mbox{}\protect\newline 5 (4-8) \mbox{}\protect\newline 1 (0.5) \mbox{}\protect\newline 27 (8.54\%) \mbox{}\protect\newline 12 (3.79\%) \mbox{}\protect\newline 167 (52.8\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
The present study was conducted in RVS Institute of Medical Sciences, Chittoor, Andhra Pradesh. In the wards of obstetrics and gynecology, especially in the postnatal ward. The materials required for the study are collected from the gynecology and obstetrics department of the hospital included in the study. The study details with all the details of aim, objective, methodology, inclusion criteria, exclusion criteria, expected outcome have been submitted to the ethical committee, and after getting a positive opinion from the institution ethics committee(IEC) towards the study, the work has been started. 

Study was conducted in the obstetrics and gynecology departments of the hospital, especially in the labor and postnatal ward. It was carried out during the period of June 2016 and December 2016. 

\textbf{Inclusion criteria}

The study included all the age groups of pregnant women brought to labor ward and shifted to postnatal ward within 1-2 days after giving birth to child. 

\textbf{Exclusion criteria}

Pregnant women admitted to antenatal ward, maternal women brought to postnatal ward after 2 days of giving birth to the child and other women admitted to the gynecology and obstetrics ward with other menstrual complaints.
    
\section{\textbf{Reports and Discussion}}
The present study was conducted in RVS Institute of Medical Sciences, Chittoor, Andhra Pradesh, in the departments of obstetrics and gynecology. The study has included all the maternal women undergone delivery during the study period of June 2018 and December 2018. The study included about 316 maternal women. All the women included in the study have been administered with Misoprostol after giving birth to the neonate to prevent the occurrence of atonic PPH, which is the most widely seen complication resulting in birth of maternal women. 

Different demographic details of the study population including primiparous and gravidae have been collected from the case reports of individual patients and are observed for time of administration of drug with respect to clinical condition and the outcomes are measured, which are represented in the Table~\ref{tw-39c887e069b7}. The mean age of maternal women was 27.8 yrs of mean, with a SD of 5.9. The maternal weight of all the women was found to be with a mean of 79.4 years with SD of 12.1., the mean(SD) maternal height of overall study population was found to be 165.1 (6.6), and the primigravidae of aver all population accounted for 145 women., gestational age of all the women with a mean of 38.9 and SD of 38.9 was evaluated.

Spontaneous onset of labor was reported in 210 women, augmentation for labor was done in 91 women, epidural analgesia was given for 176 women, narcotic analgesia was given in 92 women, first and second degree tear was noted in 123 women, 75 women required instrumental vaginal delivery due to complications involved during normal delivery like altered quantities of umbilical fluids etc. episiotomy was performed in 43 women.

Length of first stage of labor was noted with a mean of 6.6 hours in all the women with a SD of 4.0 and the mean of second stage of delivery was found to be 69, with a standard deviation of 61.

The mean birth weight of all the neonates was found to be 3.15kg with a standard deviation of 0.6, which is represented In the Table~\ref{tw-39c887e069b7}.

Various vital parameters like blood pressure, hemoglobin levels, haematocrit and temperature have been recorded in the study population. The diastolic blood pressure of all the maternal women involved in the study was recorded with a mean of 74.5 \unskip~\citep{828118:19796016}  before delivery and 74.2 \unskip~\citep{828118:19796035} after delivery with a difference of -0.3, which is interpreted to be nil significant. Thus, diastolic blood pressure does not show any variation with delivery \unskip~\citep{828118:19796022}.

The systolic blood pressure before delivery was noted with a mean of 11.8 \unskip~\citep{828118:19796016}  and 117.6 \unskip~\citep{828118:19796016} after delivery, thus it has proven that systolic blood pressure does not show any significant difference with delivery. Hemoglobin levels accounted with a mean of 12.1 before delivery and 12.0 after delivery in women, thus, administration of misoprostol has proven to prevent increased blood loss after labor \unskip~\citep{828118:19796034}. 

Haematocrit was noted as 0.43 of mean value before delivery and 0.41 after delivery \unskip~\citep{828118:19796024}. Temperature was recorded with a mean of 36.4 \ensuremath{^\circ}C before delivery and 37.2 \ensuremath{^\circ}C after delivery and the significant difference P was noted as 0.002, which was enlisted in the Table~\ref{tw-74bf4d68fab6}.

The stage of PPH and incidence of PPH in all the maternal women were observed\unskip~\citep{828118:19796026}. Blood loss more than or equal to 500 mL is referred to as first stage PPH and blood loss more than or equal to 1000 mL after within 24 hours of delivery is taken as 2\ensuremath{^{nd}} stage of PPH. 

All the women included in the study have been administered with misoprostol within 4-5hrs after delivery. The common side effects observed in the maternal women were vomiting, which was reported in 27 women out of 316 women. Diarrhea was reported in 12 women out of all study population. 

Shivering was accounted in 167 women, thus, shivering is the major side effect noted with administration of misoprostol. One women was reported with a elevated diastolic blood pressure of {\textgreater}100 mm of Hg out of 316 women. \unskip~\citep{828118:19796023}. Manual removal of placenta was necessitated in 19 women. which is represented In the Table~\ref{tw-c916d454b9d2}.
    
\section{Conclusions}
 Misoprostol was administered in all the women (n = 316) after 4- 5 hours of delivery. One women was recorded with elevated diastolic blood pressure {\textgreater}100 mm of Hg and no women was reportedly noted with systolic blood pressure {\textgreater}140 mm of Hg. More than 80\% of health care team were aware of use of misoprostol for prevention and management of PPH(21). However, it's needed to increase the mandatory guidelines for management of various complications accounted during delivery to prevent maternal mortality rate.
\section*{Acknowledgement}The authors highly acknowledge the Chairperson and Management trustee, Tagore Educational Trust, Rathinamangalam, Chennai, Tamilnadu and B.S.Abdur Rahman Crescent Institute of Science and Technology, Chennai, Tamilnadu, for providing facilities to pursue this research work.

\textbf{Funding Support }

Nil.

\textbf{Conflict of Interest}

The author does not have any Conflict of Interest in this present work.
    

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