<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD Journal Publishing DTD v3.0 20080202//EN" "http://dtd.nlm.nih.gov/publishing/3.0/journalpublishing3.dtd">
<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" dtd-version="3.0" xml:lang="en" article-type="research article">
 <front>
  <journal-meta>
   <journal-id journal-id-type="publisher-id">
    ojog
   </journal-id>
   <journal-title-group>
    <journal-title>
     Open Journal of Obstetrics and Gynecology
    </journal-title>
   </journal-title-group>
   <issn pub-type="epub">
    2160-8792
   </issn>
   <issn publication-format="print">
    2160-8806
   </issn>
   <publisher>
    <publisher-name>
     Scientific Research Publishing
    </publisher-name>
   </publisher>
  </journal-meta>
  <article-meta>
   <article-id pub-id-type="doi">
    10.4236/ojog.2024.149110
   </article-id>
   <article-id pub-id-type="publisher-id">
    ojog-136026
   </article-id>
   <article-categories>
    <subj-group subj-group-type="heading">
     <subject>
      Articles
     </subject>
    </subj-group>
    <subj-group subj-group-type="Discipline-v2">
     <subject>
      Medicine 
     </subject>
     <subject>
       Healthcare
     </subject>
    </subj-group>
   </article-categories>
   <title-group>
    Retrospective Cohort Study to Investigate Pregnancy Outcomes in a Population of Advanced Maternal Age Congolese Women of Kinshasa: A Study Protocol
   </title-group>
   <contrib-group>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Anne Kapinga
      </surname>
      <given-names>
       Mutshiaudi
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Thérèse Mikoka
      </surname>
      <given-names>
       Walumpumpu
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Nicodem Nkutu
      </surname>
      <given-names>
       Kimpu
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff2"> 
      <sup>2</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Joelle Lumaya
      </surname>
      <given-names>
       Ambis
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Andy Mbangama
      </surname>
      <given-names>
       Muela
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Roger Mbungu
      </surname>
      <given-names>
       Mwimba
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
    <contrib contrib-type="author" xlink:type="simple">
     <name name-style="western">
      <surname>
       Kahindo P.
      </surname>
      <given-names>
       Muyalalo
      </given-names>
     </name> 
     <xref ref-type="aff" rid="aff1"> 
      <sup>1</sup>
     </xref>
    </contrib>
   </contrib-group> 
   <aff id="aff1">
    <addr-line>
     aDepartment of Gynecology and Obstetrics, Cliniques Universitaires de Kinshasa, Kinshasa, Congo
    </addr-line> 
   </aff> 
   <aff id="aff2">
    <addr-line>
     aDepartment of Basic Sciences, Faculty of Medicine, University of Kinshasa, Kinshasa, Congo
    </addr-line> 
   </aff> 
   <pub-date pub-type="epub">
    <day>
     29
    </day> 
    <month>
     08
    </month>
    <year>
     2024
    </year>
   </pub-date> 
   <volume>
    14
   </volume> 
   <issue>
    09
   </issue>
   <fpage>
    1398
   </fpage>
   <lpage>
    1406
   </lpage>
   <history>
    <date date-type="received">
     <day>
      1,
     </day>
     <month>
      May
     </month>
     <year>
      2024
     </year>
    </date>
    <date date-type="published">
     <day>
      16,
     </day>
     <month>
      May
     </month>
     <year>
      2024
     </year> 
    </date> 
    <date date-type="accepted">
     <day>
      16,
     </day>
     <month>
      September
     </month>
     <year>
      2024
     </year> 
    </date>
   </history>
   <permissions>
    <copyright-statement>
     © Copyright 2014 by authors and Scientific Research Publishing Inc. 
    </copyright-statement>
    <copyright-year>
     2014
    </copyright-year>
    <license>
     <license-p>
      This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/
     </license-p>
    </license>
   </permissions>
   <abstract>
    <b>Introduction</b>: Pregnancies at advanced maternal age (AMA) are those occurring after the age of 35 years old. They carry a high risk of maternal-fetal morbidity and mortality, thus constituting a public health problem. Several African countries have reported an upward trend in both the age of childbirth and the frequency of women with AMA over the past 20 years. In the Democratic Republic of Congo (DRC), where maternal and neonatal morbidity and mortality remain very high, data on AMA pregnancies go back more than 20 years. 
    <b>Objective</b>: We propose evaluating obstetrical outcomes among women in AMA in our setting and the associated factors. 
    <b>Methods</b>: This retrospective cohort study will be conducted in two healthcare facilities (ESS) in Kinshasa. The study population will consist of all women who delivered a single fetus after 28 weeks of gestation between January 2012 and December 2022 (10 years) in the selected ESS. The data collected will be analyzed using R software version 4.2.0. Quantitative variables will be summarized as means with standard deviation or medians with interquartile range. Qualitative variables will be presented as proportions (%). Multivariate logistic regression will be used to determine the main maternal-fetal complications associated with AMA and predictors of obstetric outcomes. P &lt; 0.05 will be considered statistically significant. Results will be presented in tabular and graphical form. 
    <b>Discussion</b>: The high maternal and infant mortality rates in DRC are among the highest in the world. The context of maternal age has become a topic of growing interest due to its potential implications for the health of women and newborns, it is crucial to identify the risk factors associated with obstetric outcomes by identifying obstetrical outcomes associated with advanced maternal age in the DRC. Many Congolese women tend to start their maternity journey at a relatively young age. However, there is also an emerging trend towards delayed childbearing, particularly in urban areas and among women with access to education and family planning services. 
    <b>Conclusion</b>: The results of this study will enable us to update the frequency of AMA pregnancies in our environment. The socio-demographic and clinical profile of these pregnancies will be determined. The main maternal-fetal complications associated with AMA in our setting and the associated factors will be identified. 
   </abstract>
   <kwd-group> 
    <kwd>
     Advanced Maternal Age
    </kwd> 
    <kwd>
      Adverse Maternal and Perinatal Outcome
    </kwd> 
    <kwd>
      Congolese Women
    </kwd> 
    <kwd>
      Kinshasa
    </kwd>
   </kwd-group>
  </article-meta>
 </front>
 <body>
  <sec id="s1">
   <title>1. Introduction</title>
   <sec id="s1_1">
    <title>1.1. Background and Rationale</title>
    <p>Any pregnancy contracted after the age of 35 years old is considered to be an advanced maternal age (AMA) pregnancy. Fertility specialists refer to late-onset pregnancies from the age of forty onwards <xref ref-type="bibr" rid="scirp.136026-1">
      [1]
     </xref>.</p>
    <p>AMA pregnancies are high-risk pregnancies in terms of maternal-fetal morbidity and mortality and are a matter of public health concern. This risk is increased by the physiological and physical changes associated with age, as well as the morbid histories of pregnant women, such as uterine myomectomy or cesarean section scars <xref ref-type="bibr" rid="scirp.136026-2">
      [2]
     </xref>.</p>
    <p>Several studies have described risks such as high blood pressure, pre-eclampsia, gestational diabetes, miscarriage, cesarean section, and even death for the mother <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref>. According to CNGOF (Collège national des gynécologues et obstétriciens français), chronic hypertension and diabetes are the two most frequent pathologies associated with AMA <xref ref-type="bibr" rid="scirp.136026-4">
      [4]
     </xref> <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref> In the case of diabetes mellitus, the risk is multiplied by 4 for women aged between 40 and 50, compared with women aged between 20 and 34 <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref>. Pre-eclampsia (PE) is one of the leading causes of maternal mortality <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref> <xref ref-type="bibr" rid="scirp.136026-6">
      [6]
     </xref>. In France, 8% of deaths are linked to PE, and this risk is multiplied by 2 for women over 40, regardless of parity <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-6">
      [6]
     </xref>. According to a study by Cleany-Goldman et al., AMA is significantly associated with a higher risk of retroplacental hematoma (RPH) in women over 40 than in those under 35 <xref ref-type="bibr" rid="scirp.136026-4">
      [4]
     </xref>. Fetal presentation abnormalities may partly explain the increased rate of cesarean sections and spontaneous miscarriages.</p>
    <p>Complications in newborns have also been reported, including chromosomal abnormalities, prematurity, low birth weight, and macrosomia <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref> <xref ref-type="bibr" rid="scirp.136026-4">
      [4]
     </xref>. According to Warburton, the rate rises to 33.8% after age 40, compared with 11.7% between 30 and 34, 17.7% between 35 and 39 and 53.2% after 45 <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref>. At least 60% of early abortions are linked to age-related chromosomal aberrations <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref>. The risk of chromosomal aberration is 1.6% at 38, 2.21% at 40, and 4% at 42 <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref>. In terms of birth weight, women over 40 are more likely to have a low birth weight (18.6%) than women under 35 (11.3%) <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-7">
      [7]
     </xref>. In a study in Ethiopia, adverse fetal outcomes, including stillbirth and premature birth, were significantly associated with pregnancy at advanced maternal age <xref ref-type="bibr" rid="scirp.136026-6">
      [6]
     </xref> <xref ref-type="bibr" rid="scirp.136026-8">
      [8]
     </xref>. In a study in the Democratic Republic of Congo (DRC) in the province of Haut Katanga, more precisely in Lubumbashi, advanced maternal age was associated with perinatal mortality <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref>.</p>
    <p>Over the past four decades, the transition from high to low fertility has been observed in most parts of the world, including Africa <xref ref-type="bibr" rid="scirp.136026-8">
      [8]
     </xref> <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref>. This reduction in fertility is associated with an increase in the age at childbirth and the frequency of women with AMA <xref ref-type="bibr" rid="scirp.136026-10">
      [10]
     </xref>. According to a WHO survey of three continents (Latin America, Middle East, and Africa) from 2010 to 2011, the overall prevalence of women with AMA was 12.3% <xref ref-type="bibr" rid="scirp.136026-4">
      [4]
     </xref>. In Canada, the proportion of women with AMA rose from 15% in 1998 to 18% in 2007, and 1 primiparous woman in 3 was aged over 35 <xref ref-type="bibr" rid="scirp.136026-7">
      [7]
     </xref>. In France, the proportion of women undergoing AMA rose from 19% in 2010 to 21% in 2016 <xref ref-type="bibr" rid="scirp.136026-7">
      [7]
     </xref>. Several African countries have also reported an increase in the frequency of pregnancy postponements (a concept referring to the decision to schedule one’s pregnancy at a later date. This may be due to a variety of factors, such as personal, professional, or medical circumstances and AMA <xref ref-type="bibr" rid="scirp.136026-8">
      [8]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-10">
      [10]
     </xref>. Longer periods of study for women, family planning, and the advent of medically assisted reproduction (MAP) are the main reasons for the rise in these frequencies <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref> <xref ref-type="bibr" rid="scirp.136026-11">
      [11]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-13">
      [13]
     </xref>.</p>
    <p>Maternal mortality has reached unacceptable levels worldwide <xref ref-type="bibr" rid="scirp.136026-8">
      [8]
     </xref>. Almost all maternal deaths (99%) occur in developing countries, with 62% in sub-Saharan Africa (179,000) <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref>. The DRC is one of the countries in Sub-Saharan Africa with one of the highest maternal mortality ratios, estimated at 547 maternal deaths per 100,000 live births <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref> <xref ref-type="bibr" rid="scirp.136026-14">
      [14]
     </xref>. The underlying causes of these maternal and neonatal deaths are complex and multifactorial <xref ref-type="bibr" rid="scirp.136026-10">
      [10]
     </xref>, including advanced maternal age <xref ref-type="bibr" rid="scirp.136026-11">
      [11]
     </xref>. Indeed, as a consequence of the fertility transition, an increase in the proportion of women with AMA in our environment could contribute to the persistence of the high risk of maternal and perinatal morbidity and mortality <xref ref-type="bibr" rid="scirp.136026-10">
      [10]
     </xref> <xref ref-type="bibr" rid="scirp.136026-15">
      [15]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-19">
      [19]
     </xref>.</p>
    <p>In the DRC, where maternal and neonatal morbidity and mortality remain very high, there is very little data on AMA and its impact on pregnancy outcomes. Also, data concerning AMA pregnancies date back more than 20 years <xref ref-type="bibr" rid="scirp.136026-20">
      [20]
     </xref> <xref ref-type="bibr" rid="scirp.136026-21">
      [21]
     </xref>. Hence, there is an interest in carrying out this study.</p>
   </sec>
   <sec id="s1_2">
    <title>1.2. Objectives</title>
    <p>To assess obstetric outcomes in advanced maternal age in our setting and the factors associated with them.</p>
    <sec id="s1">
     <title>2. Materials and Methods</title>
    </sec>
    <sec id="s2_3">
     <title>2.1. Type of Study and Survey Period</title>
     <p>The study will be a retrospective cohort study. The survey will run from January 2012 to December 2022, i.e. for 10 years.</p>
    </sec>
    <sec id="s2_4">
     <title>2.2. Study Population</title>
    </sec>
    <sec id="s2_5">
     <title>2.3. Sampling</title>
     <p>All women who gave birth during our data collection period and who met our inclusion criteria.</p>
     <p>The minimum sample size will be calculated according to the following formula:</p>
     <p>
      <math display="inline" xmlns="http://www.w3.org/1998/Math/MathML"> <mrow> 
        <mi>
          n 
        </mi> 
        <mo>
          = 
        </mo> 
        <mfrac> 
         <mrow> 
          <msup> 
           <mi>
             Z 
           </mi> 
           <mn>
             2 
           </mn> 
          </msup> 
          <mi>
            p 
          </mi> 
          <mrow> 
           <mo>
             ( 
           </mo> 
           <mrow> 
            <mn>
              1 
            </mn> 
            <mo>
              − 
            </mo> 
            <mi>
              p 
            </mi> 
           </mrow> 
           <mo>
             ) 
           </mo> 
          </mrow> 
         </mrow> 
         <mrow> 
          <msup> 
           <mi>
             d 
           </mi> 
           <mn>
             2 
           </mn> 
          </msup> 
         </mrow> 
        </mfrac> 
       </mrow> 
      </math></p>
     <p>where</p>
     <p>n: is the minimum sample size required;</p>
     <p>Z = 1.96 (95% confidence at the significance level of 0.05);</p>
     <p>p = 50% (assumed prevalence of obstetrical outcomes in AMA);</p>
     <p>d = 0.05 (desired margin of error).</p>
     <p>Consequently,</p>
     <p>
      <math display="inline" xmlns="http://www.w3.org/1998/Math/MathML"> <mrow> 
        <mi>
          n 
        </mi> 
        <mo>
          = 
        </mo> 
        <mfrac> 
         <mrow> 
          <msup> 
           <mrow> 
            <mn>
              1.96 
            </mn> 
           </mrow> 
           <mn>
             2 
           </mn> 
          </msup> 
          <mo>
            × 
          </mo> 
          <mn>
            0.5 
          </mn> 
          <mrow> 
           <mo>
             ( 
           </mo> 
           <mrow> 
            <mn>
              1 
            </mn> 
            <mo>
              − 
            </mo> 
            <mn>
              0.5 
            </mn> 
           </mrow> 
           <mo>
             ) 
           </mo> 
          </mrow> 
         </mrow> 
         <mrow> 
          <msup> 
           <mrow> 
            <mn>
              0.05 
            </mn> 
           </mrow> 
           <mn>
             2 
           </mn> 
          </msup> 
         </mrow> 
        </mfrac> 
        <mo>
          ≥ 
        </mo> 
        <mn>
          384 
        </mn> 
       </mrow> 
      </math></p>
     <p>We will use three levels of cluster sampling:</p>
     <p>Data will be collected from medical records and registers in the delivery room and operating theatre.</p>
     <p>Variables of interest:</p>
    </sec>
    <sec id="s2_6">
     <title>2.4. Data Organization and Processing</title>
     <p>Data will be organized in Excel spreadsheets before analysis using R software version 4.2.0.</p>
    </sec>
    <sec id="s2_7">
     <title>
      <xref ref-type="bibr" rid="scirp.136026-"></xref>2.5. Analyses des Données</title>
     <p>Based on previous studies <xref ref-type="bibr" rid="scirp.136026-23">
       [23]
      </xref>, we will compare maternal and perinatal outcomes in different groups using women aged 20 to 29 as a reference group. In addition, this age group corresponds to the optimal age for childbearing in Africa <xref ref-type="bibr" rid="scirp.136026-24">
       [24]
      </xref> <xref ref-type="bibr" rid="scirp.136026-25">
       [25]
      </xref>.</p>
     <p>Age group:</p>
    </sec>
    <sec id="s2_8">
     <title>2.6. Expected Results</title>
     <p>Ethics and dissémination</p>
     <p>This project was approved by the Department of Gynecology-Obstetrics and has been submitted to the Ethics Committee of the School of Public Health of the University of Kinshasa for approval. Information will be collected, processed, and published anonymously and confidentially.</p>
    </sec>
   </sec>
   <sec id="s3">
    <title>3. Discussion</title>
    <p>The Democratic Republic of Congo (DRC) faces major maternal health challenges, with high maternal and infant mortality rates. According to the World Health Organization (WHO), the maternal mortality rate in the DRC is among the highest in the world, with around 473 deaths per 100,000 live births <xref ref-type="bibr" rid="scirp.136026-5">
      [5]
     </xref> <xref ref-type="bibr" rid="scirp.136026-9">
      [9]
     </xref> <xref ref-type="bibr" rid="scirp.136026-20">
      [20]
     </xref> <xref ref-type="bibr" rid="scirp.136026-21">
      [21]
     </xref>. In this context, it is crucial to identify the risk factors associated with obstetric outcomes to develop effective interventions to reduce maternal morbidity and mortality <xref ref-type="bibr" rid="scirp.136026-26">
      [26]
     </xref> <xref ref-type="bibr" rid="scirp.136026-27">
      [27]
     </xref>.</p>
    <p>Advanced maternal age has become a topic of growing interest due to its potential implications for the health of women and newborns. The main objective of this study is to identify obstetrical outcomes associated with advanced maternal age in the DRC, as well as the underlying risk factors <xref ref-type="bibr" rid="scirp.136026-3">
      [3]
     </xref> <xref ref-type="bibr" rid="scirp.136026-4">
      [4]
     </xref> <xref ref-type="bibr" rid="scirp.136026-20">
      [20]
     </xref> <xref ref-type="bibr" rid="scirp.136026-21">
      [21]
     </xref>. Although precise data on maternal age in the DRC are limited, it is widely recognized that many Congolese women tend to start their maternity journey at a relatively young age. However, there is also an emerging trend towards delayed childbearing, particularly in urban areas and among women with access to education and family planning services <xref ref-type="bibr" rid="scirp.136026-15">
      [15]
     </xref> <xref ref-type="bibr" rid="scirp.136026-22">
      [22]
     </xref>-<xref ref-type="bibr" rid="scirp.136026-26">
      [26]
     </xref>.</p>
   </sec>
   <sec id="s4">
    <title>4. Conclusions</title>
    <p>With the increased frequency of postponement of the first birth, this study will update data on obstetrical outcomes in AMA in the Kinshasa population. By identifying adverse maternal and neonatal outcomes, we will be able to understand better the challenges faced by women of advanced age in the DRC.</p>
    <p>In addition, this study will examine the risk factors associated with these obstetric outcomes, including medical history, socio-economic status, and other relevant variables. This analysis will allow us to identify high-risk populations and direct prevention and intervention efforts towards the most vulnerable women.</p>
    <p>We will test the hypothesis that advanced maternal age increases the risk of obstetric complications of pregnancy.</p>
   </sec>
   <sec id="s5">
    <title>Strengths of the Study</title>
    <p>Our study will be the first after 20 years to evaluate the advanced maternal age and obstetric outcomes in the population of Kinshasa.</p>
    <p>The consistency of the result of this study will offer the updating in the hypothesis that advanced maternal age increases the risk of obstetric complications of pregnancy, and that according to socio-economic changes of population and new concepts of gender in DRC.</p>
   </sec>
   <sec id="s6">
    <title>Study Limitations</title>
    <p>Our sample will not be representative of the city of Kinshasa and future studies will have to take this into account.</p>
    <p>The prospective nature of the study can face the loss of some data.</p>
   </sec>
   <sec id="s7">
    <title>Disclosure</title>
    <p>The authors report no conflicts of interest for this work.</p>
   </sec>
  </sec>
 </body><back>
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