Women's Birth Experience and Neonatal Outcomes, Study Design and Methodology with Baseline Characteristics. A Hospital-Based Maternal Follow-up Study

Background: Giving birth is a joyful, unique event and a highly individual experience in a woman's life. Childbirth experience has a signicant role in developing self-condence and positive feelings for the newborn. This experience is affected by many factors, including the mode of delivery. This paper tries to depict the experience of labor, delivery, and neonatal outcomes observed during the implementation of labor and delivery outcome study at selected hospitals in Eastern Ethiopia hospitals. Method: A hospital-based follow-up study was implemented in Hiwot Fana and Jegula Hospital in Harar, Bisidimo hospital in Eastern Hararghe, Oromia, and Dil-Chora Hospital in Dire Dawa from June 2020 to October 2020. A total of 2246 women with labor experience visited the hospitals were followed from delivery until discharge to document their experience and neonates' outcomes. Data were collected through a face-to-face interview using a structured pre-tested questionnaire. A Phenomenological approach qualitative study design will also be employed from April to May 2021. The women who give birth to normal single-term newborns through vaginal or a cesarean section will be included in the study. Women with stillbirth twin, preterm and congenital malformation, serous ill neonates, and who admitted to for more than one week will be excluded because those women will be extreme or deviant cases. In-depth interviews coupled with tape recording and note-taking will be to collect the data. A semi-structured interview guide will consider four domains of the Roy adaptation theory: an open-ended question (physiological, self-concept, role and function, and interdependence). Translated les will be transferred to open code software in a plain text format. Coding and categorization will be done on a system to generate a synthesized theme.


Introduction
Globally near to three hundred eighty-six thousand women pass through the birth process every day (1), and women experience motherhood with feelings of happiness and challenges. Women's birth experience is in uenced by perception or expectation during pregnancy, health service delivery system, support system, and delivery mode (2)(3)(4)(5).
Maternity healthcare's primary purpose is to save women and their babies lives, to achieve this hospital system work hand in hand to ensure patient's safety and health condition (6). Besides delivering clinical care speci c to labor and childbirth, it also means making sure that women are treated with respect and support. Continuity of care, regular monitoring and documentation of events, and clear communication between medical practitioners and clients are essential, ensuring that a referral plan is in place should more advanced medical care become necessary. These are all crucial elements that provide a positive birth experience (7). An effective referral system is an essential element of the health system to improve mothers and newborn outcomes(8). However, in developing countries, the referral system is not based on professional assessment; instead, it depends on women's preferences, and more than half of referrals are self-referral in the nations (9).
Labor can be a frightening experience for women; a safe hospital environment and continuous support would help the women relax and develop a positive experience (10,11), also; it reduces the need for medical intervention and improves maternal and neonatal outcomes (12,13). In most instances, women who delivered at health institutions safer from lack of respectful care, privacy, especially during pelvic examination and delivery, institutional regulation of not having a birth companion, and lack of emotional and physical support (14). Studies indicate that the mode of birth is also associated with a birth experience (15,16).
The natural delivery mode is considered the safest for neonates. However, if this method is not achieved, operative vaginal or cesarean section (CS) is needed. (17). In most instances, operative vaginal or CS modes of delivery are associated with adverse maternal and neonatal outcomes. The common adverse neonatal outcomes related to operative vaginal or cesarean deliveries are Respiratory Distress Syndrome, Cephalohematoma, Shoulder Dystocia, feeding di culties, Retinal hemorrhage, low Apgar score, Neonatal Intensive Care Unit (NICU) admission, mechanical ventilation, and neonatal deaths (17)(18)(19)(20) The best mode of delivery to improve maternal and neonatal outcomes remains the dilemma for obstetricians. However, the global adequate CS rate and the increasing number of CS deliveries have been debated among health care providers because most deliveries occur in Sub-Saharan Africa (21,22). In Ethiopia, the CS rate has also been increased dramatically from 0.7% in 2000 to 1.9% in 2016 (23).
Little is known about women's birth experience and its neonatal outcome. We are undertaking this maternal surveillance study to address this gap, focusing on admission, delivery through postpartum, and discharge. The study will investigate women's birth experience, neonatal outcome, and trial of labor outcomes. This paper tries to depict the population and ow of study. This analysis will give a baseline on the status of obstetrics care and supports developing new guidelines and strategies to improve maternal and newborn care.

Methods And Materials
A study Area This maternal surveillance study is a hospital-based prospective follow-up study of women's birth experience and its outcomes carried out in two rounds. The rst participants were enrolled in the study from June 1, 2020, to October 30, 2020. The second round will commence from April 1, 2020, and the qualitative data collection is expected to end on May 30, 2021. The hospitals included in the study were from Eastern Hararghe (Oromia region), Harari region, and Dire Dawa administration. There are nine government hospitals in the study area altogether, one specialized hospital (Hiwot Fana Hospital), one referral hospital (Dil-Chora hospital), ve generals/secondary hospitals, and two primary hospitals. In this study, Hiwot Fana and Jegula Hospital from Harar, Dil-Chora Hospital from Dire Dawa, and Bisidimo Hospital from Eastern Hararghe were included (Figure_1).

Hiwot Fana Specialized Hospital (HFSH)
HFSUH is one of the oldest hospitals in Harar, established during the Italian occupation (1928)(1929)(1930)(1931)(1932)(1933). In the recent two-three decades, the hospital becomes a teaching facility for health sciences students for Haramaya University. It has a total of 233 beds for admission. The annual number of patients visiting the hospital reached 114,650, with an average of 11,957 admissions per year. (24). The maternity unit offers service for about 5808 deliveries annually and provides 830 caesarian deliveries annually (25). Babies born with adverse outcomes are transferred to a 15 beds neonatal intensive care unit (NICU). It admits 124 neonates per month on average.

Jugal Hospital
Jugal hospital is also the oldest hospital in Ethiopia. It was built in 1957 EC by King Haile Selase in memory of his father, Ras Mekonen. The maternity unit has six prenatal beds, two delivery couches, one newborn resuscitation bed, and eight postnatal beds. In this unit, on average, 3000 deliveries are conducted annually. Neonates with health problems are admitted to the NICU. It has six beds, three incubators, three radiant warmer, and one oxygen tanker. On average, 30 neonates are admitted per month, and severe cases are referred to Hiwot Fana (26).

Dil-Chora Hospital
Dil-Chora hospital is the largest and referral facility in Dire Dawa. The hospital has six wards and an ICU with a total of 353 beds. Around 193 485 patients visit the hospital annually, nearly 17,512 patients visit the hospital for inpatient service per year. The maternity ward gives service for laboring women and their babies. In this ward, there are three departments (delivery, maternal, and child health (MCH) and NICU) (27).

Bisidemo Hospital
Bisidimo Hospital is in eastern Hararghe, Babile district, 20 km away from Harar eastwards. It was established in 1958 by Deutsches Aussãtzigen Hilfswerk (DAHW) (German Leprosy Relief Organization). Bisidimo hospital is the center of leprosy in the East Hararghe zone of the Oromia region. The hospital provides service for 1700 laboring women annually and has one emergency surgeon(28).

Study design for Quantitative Studies
This is a follow-up study capturing pregnant women on arrival to the labor ward to follow through delivery, postpartum, and discharge. A total of 2246 pregnant women who visited the selected hospital for labor were included to document their labor, delivery, discharge experiences, and outcomes. The follow-up started on admission. At the entrance, past and current maternal history were taken from the women. The women were followed through observation during labor/delivery. The maternal chart was also reviewed to get information to meet the required information for analysis; after delivery, neonatal outcomes were assessed and followed until discharged from the hospital. The women who had previous CS and tried vaginal delivery were included in the study. (Figure 2)

Study Population and sampling
This study's source populations were all women who attended the hospitals for labor and delivery during the study period. Among these, women who delivered a live baby and volunteer to participate in the study were included. Based on the hospitals' information available, approximately 7,000-8000 women gave birth in the previous six-month period. More than 50% of these were from rural areas, and of these, 25% were from Haramaya, Aweday, Fedis, Konbolicha, and Jarso. (Figure 2).
A total of 2246 women were recruited at admission. Systematic random sampling was used to select the participants; N/n==7,536/2246=3.35. (Figure3) Sample size determination.
The sample size for each objective was determined using online Epi-Open software (Table 1) Inclusion and Exclusion Criteria Women who have visited the hospitals for delivery with their babies were included. Women who were given birth at home or other facilities and visited the hospitals for the management of complications were excluded. Women with critical medical conditions and women with known intrauterine fetal death were excluded from the study.

Enrollment and Follow-up
Recruitment of study participants took place at the delivery ward of selected hospitals. Women who ful ll the inclusion criteria were explained and invited by the trained research assistants to participate in the study. Once the women accepted the invitation, they were asked for consent. The data collectors gather baseline information on sociodemographic characteristics and maternal information from health professional/medical records. A maternal chart review was also done to get information about labor and the outcomes.
The cohort identi cation number was lled for enrolled participants and informed them to keep this sheet after delivery. The cohort number was also written on the maternal chart to trace back those who missed the sheet. All women delivered vaginally (spontaneous and operative vaginal delivery) and cesarean section (emergency and Elective CS) were included in the study. The newborns were followed from the time of delivery to discharge from the hospital.

Data Collection and instrument
Four female midwives and two neonatal nurses from respective hospitals were selected and trained to collect the data. The research team supervises data collection. A structured questionnaire translated into local languages (Amharic Afan-Oromo and Somali) was used for data collection.
Socio-demography, economic condition, past-current obstetric history, and labor-delivery information including party, gravid, current and previous obstetric history, antenatal care(ANC), history of previous CS, history of successful Vaginal birth after CS(VBAC), history stillbirth, birth interval, delay the second stage of labor Premature Rupture of Membrane(PROM), cephalo-pelvic disproportion (CPD), induced labor, and gestational age and mode of delivery were collected using several forms. Fetal and neonatal information includes mal-presentation, position, sex, and weight. The baby's outcomes include trauma, hypothermia, MAS, and breastfeeding di culty, were assessed using a physical examination checklist ( Table 2).

Quality Control
The questionnaire was pre-tested for consistency and validity in one of the nearby hospitals, Haramaya hospital, which is not part of the study. For wealth index and major neonatal outcome, validated tools were used. Adequate training was given for data collectors and supervisors. The focal persons and principal investigators closely followed the data collection process and ensured complete data consistency. Any error, ambiguity, incompleteness, or any other problems were addressed the following day. Data were double entered into Epi Data software to check for the agreement of data.

Data Management
Data were entered using the EpiData and exported to STATA Statistical for analysis, and it was cleaned, edited, and recorded before analysis. Cleaning was done through visual inspection, running frequencies, and cross-tabulation. The error was corrected by checking the questioner's hard copy, and for some ambiguous answers, the data collectors were asked to get clarity. Besides, the maternal chart and registrations were checked.
Missing data were handled using complete case analysis, missing coding values as separate categories, imputation methods, and/or sensitivity analyses. Some variables were recorded to make a clear interpretation, and the new variables were generated from the existing one. Then descriptive statistics was using numbers, percentages, mean, and standard deviation were done. This study's outcomes are categorical, and the appropriate statistical test is the chi-square test or Fisher's exact test to analyze the relationship between the variables with p < 0.05.

Study design for Qualitative Studies
Phenomenological (cf Husserl, Heidegger) approach qualitative study design will be employed Aprile to May 2021. The phenomenological approach aims to develop a complete, accurate, clear, and articulate description and understanding of a particular human experience or experiential moment (32).

Study population
The study participants will be all women who give birth at selected hospitals. The women who give birth to normal single-term newborns through vaginal or a cesarean section will be included in the study.

Inclusion criteria and Exclusion criteria
All women with a singleton term, without pregnancy-related complication, like mothers with APH, Preeclampsia, eclampsia, and diabetics melts, and who can talk to the local language, will be included in the study. On the other hand, women with stillbirth twin, preterm and congenital malformation, serous ill neonates, and who admitted to for more than one week will be excluded because those women will be extreme or deviant cases.

Sampling technique
Women visiting the two hospitals for labor and delivery one to two weeks before the interview will be interviewed. This framework allows us to get fresh memory of women's birth experiences. To get in-depth information and to indicate different backgrounds, women will be categorized into two groups based on the mode of delivery and the number of delivery exposure. The women will be categorized into two groups. The women give birth by vaginal delivery and cesarean section; then these will be further divided into sub-groups. The rst subgroup will be primiparous women, the women who have no previous exposure for delivery. These women will have a different experience because their perception about childbirth, emotional readiness, and delivery room environment might affect their experience. Still, those women who have previous delivery exposure would not be affected by such factors. Women who had previous CS scare and delivered by vaginal delivery will be the second sub-group.
To illustrate these particular subgroups of interest and facilitate comparisons, strati ed purposeful sampling will be employed. Strati ed purposeful samples are samples within samples where each stratum is fairly homogenous. The purpose of strati ed purposeful sampling is to capture major variations even though a common core may also emerge in the analysis ( (33). It is also helpful for examining the variations in the manifestation of a phenomenon as any key factor associated with the phenomenon is varied. (34).

Sample size
The sample size is determined based on the level of information saturation and the variety of ideas among the sub-groups. Data saturation involves sampling until no new information is obtained and redundancy is achieved. A minimum of 3 women from each group will be interviewed.

Participants' recruitment
Before the preliminary recruitment visit is conducted in the health institutions to discuss with the women, during this visit, information will be provided on volunteer participation, the study's aim, method, and to get verbal consent for the prospective home visit re-visit in the hospital. The full address of volunteers will be taken during this period, and the convenient place and time of the interview will be arranged within the rst two weeks of delivery.

Data collection procedure
The trained facilitator will conduct in-depth interviews coupled with tape recording and note-taking in the natural setting. A semi-structured interview guide will be used for a dynamic operation between the researcher and the study participants. The guide will include four domains of the Roy adaptation theory: an open-ended question (physiological, self-concept, role and function, and interdependence) and some additional questions. Before the interview, written informed consent will be secured from the participant. Detailed information will be given to the women about its bene t, risks, and potential termination if they do not like to continue with the discussion. The interviewer will inform about ensuring con dentiality and the use of data.
The in-depth interviews will be conducted by two data collectors and one facilitator who can uently speak Amharic and Afan Oromo. When one data collector is the interviewer, the second will be the notetaker, and the lead researcher facilitates the interview. English version interview guide will be translated into Amharic and Afan Oromo language. All interviews will be audio-recorded. The women will be interviewed in a separate room.
After the opening question, to encourage the participant to describe their experience probing words will be used. This includes "Tell me more," "what will next," and"please elaborate." nally, the opportunity will be provided for the participants for further discussion. Notes will be taken parallel to the interview. The note taker will record the women's reactions such as laughter, crying, eye contact, facial expression, a sign of fear and discomfort. The facilitator will transcribe the data daily.

Data processing and analysis
The audiotape's records will be transcribed verbatim to Amharic and translated to English. The consistency of translation will be checked with the records and notes taken. Translated les will be transferred to open code software in a plain text format. Coding and categorization will be done on a system to generate a synthesized theme. Based on existing and emergent themes, ideas meanings will be generated. Themes identi ed from literature are: getting ready fear and anxiety from labor pain, lack of information and unfamiliarity with the process of labor and the delivery room, the need for support, the support of a midwife, husband, family, and friends, the role of the relationship with caregivers and the father during delivery, privacy, perceived control, emotion, satisfaction, rst moments with the baby, imagining a second pregnancy.
The analysis will be done theme by theme to give meaning based on memos generated from each code and category. Data analysis will be done following each interview to learn, understand, and consolidate each theme and research group's information. Lastly, validation and nalization will be done, and the experiences of two groups of women will be narrated substantiated with quotations.

Data quality
The trustworthiness of data will be kept throughout the procedure, using ve common methods. After nishing the interview, the interviewer summarized the participants' responses to increasing the data's credibility, who could approve the data's exactness. The nding will be checked by the researcher and senior researchers to address credibility using peer debrie ng. During data collection, the interviewer used the same interview guide for each participant for probing data. A note will be taken for an unusual reaction of the participant to address dependability.
The researchers also checked the purposes, methods, and procedures to enhance the rigor of research ndings. The complete transcription will be matched with the audio records to con rm the consistency of the result. Several methods will be used to achieve a high level of validity and quality in the data, which is the particular concern of qualitative study; emphasis will be given for con dentiality, to create comfort and comfortable environment for the participants to share more intimate details and to engage in more comprehensive descriptions of their experiences.
Besides, the pre-test will be done to validate the interview guide at Haramaya hospital, and correction will be taken accordingly to obtain a rich data set. Transferability will also be addressed using a purposive sampling method to get information-rich participants, and during the interview, the researcher tried to get in-depth information.

Discussion
The prospective follow-up study was set to explore women's birth experience and investigate neonatal outcomes. This paper tried to describe maternal and baby recruitment ow to the survey and characterize the study population as a background for other analysis as a baseline.
The total number of women included in the study was 2246, and 2117 singleton babies were included. The magnitude of cesarean section delivery was 32 %, almost similar to studies conducted in other Ethiopian parts (35)(36)(37)(38).
Despite increased CS rates, neonatal outcomes have not improved (39, 40). Women's birth experience also varies due to this change in the mode of delivery(41). The follow-up study using quantitative and qualitative methods helps to have a better understanding of the subject under discussion; both the health professional and the participant bene ted from this type of study. The health profession recognized the bene ts and risks of cesarean section and women's feelings about the service they offer, which may provide an essential clue to develop new strategies to increase the quality.
This study tried to include clients at the rst level and referral hospital, which provides a good mix of the client's character. It has also followed a large number of pregnant women through the labor and delivery process using a combination of methods, including interview, observation, and chart review. It has also tried to show the gap of service given at the hospitals using a qualitative investigation. Authors would like to alert readers that the follow-up was started at the time of labor; this might lead to missed some critical variable, such as the pattern of weight gain, BMI, preference of mode delivery at the rst, second, and third trimester, and the neonates were followed only until the discharge from the hospital, which might not give a complete picture of the neonatal period.

Consent for publication
Not applicable

Availability of data and materials
All the data of this study are available from the corresponding author upon request

Competing interests
The authors declared that they have no competing interests

Funding
The study is Ph.D. work, and the author(s) disclosed receipt nancial support for data collection from Haramaya University as part of higher education research sponsorship.    Figure 1 Map of the study area Note: The designations employed and the presentation of the material on this map do not imply the expression of any opinion whatsoever on the part of Research Square concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. This map has been provided by the authors. Study ow and population for maternal surveillance study, eastern Ethiopia The previous six-month report of women who visited the hospitals for delivery and samples size selected proportionally from the respective hospitals