8th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology

Health Service Quality Improvement after Normal Delivery Competency-Based Training Package

Research Project Proposal

S. Hadijono
Indonesia

The aim of the study: To compare the impact on health provider's clinical skills after competency-based training on active management versus expectant management of normal delivery in basic maternal health care service. The influence of the training on the evidence of postpartum hemorrhage and the influence of the normal delivery competency-based training with active management of third-stage of labor at the incidence of delivery complications, maternal and perinatal morbidity and mortality.

Methodology: "Randomized controlled clinical trial".

The benefit of the research: To understand and have the experience on the advantage and disadvantage of active management of third-stage of labor in the effort to decrease the evidence of postpartum hemorrhage and maternal and perinatal morbidity and mortality. To provide a national standard clinical procedure in management of normal delivery with active management of third-stage of labor.

Location of research: Multi-center study in Indonesia, involving specific areas that has been conducted normal delivery basic maternal health care training for health service providers.

Sample criteria: Every woman at the first-stage of delivery with a life intrauterine singleton pregnancy, at-term pregnancy, head presentation and predicted for a normal delivery.

Intervention Pregnant women who intended to deliver their babies normally, received randomly an examination to determine the boundaries of the risk of pregnancy and delivery. In the low-risk group, both standardized management of normal delivery with expectant and active management of third-stage of labor was executed by a competent health care provider who has received the competency-based normal delivery basic maternal health care training. Normal delivery competency-based training package consists of high-risk pregnancy screening, management of first stage pregnancy using partogram, management of second stage delivery, third-stage active management and newborn care.

Outcome measurement: Evaluation on the outcome of the delivery was based on the amount of third-stage hemorrhage, the incidence of postpartum hemorrhage, delivery complications, and the evidence of maternal and neonatal / perinatal morbidity and mortality in comparison with the control group who has served expectant (physiological) third-stage management and baseline data before the training has been done.

INTRODUCTION

Postpartum hemorrhage is one of the most common causes of 585,000 annual worldwide maternal deaths during pregnancy and delivery. Of these, 99% were found in developing countries, including Indonesia. Postpartum hemorrhage has become the most important complication during the third stage of labor (the stage between newborn delivery and placental delivery). Any effort to decrease maternal morbidity and mortality can not be separated from active management of labor which includes to minimize the risk of postpartum hemorrhage.

Pathologic delivery and its complications usually begin with predicted normal delivery. Based on this experience, it is reasonable to closely observe and evaluate every normal delivery by early detection of significant abnormal deviation in order to prevent complications.

Normal delivery competency-based training package consists of: high-risk pregnancy screening, management of first-stage pregnancy using partogram, management of second-stage delivery, third-stage active management and newborn care.

The aim of the clinical skills training package is to train health service providers to become competent in providing the service, preventing and managing delivery complications and other health problems associated with normal delivery.

The training course is designed for clinicians (physicians, nurses and midwives). The course builds on each participant's past knowledge and takes advantage of his/her high motivation to accomplish the learning tasks in the minimum time. The training emphasizes on practical aspects, not just knowing, and uses competency based evaluation of performance. As a result, the training will also generate standard guidelines and clinical procedure.

Every effort has been made to prepare these guidelines and standard clinical procedures to ensure that they are of practical value and can be continuously evaluated.

Third-stage active management in this training consists of oxytocin injection shortly after newborn delivery, early umbilical cord clamping and controlled cord traction (CCT) for delivery of the placenta.

STATEMENT OF PROBLEMS

In Indonesia, there has been an increasing demand for health services at all levels of the health system. The major problems have been related to the lack of good information regarding human resources and the need to develop clear concepts and strategies to resolve some major problems and imply changes in the workforce in health.

1. Enhancing the quality of human resources, the quality of life and life expectancy, family and community welfare and community awareness of the importance of pursuing a healthy life style.
2. Further developing integrated health management, including monitoring of appropriate medical technology, enhancing the quality of health services, expanding the capabilities of the health system and increasing the accessibility to services, particularly for the low-income population.
3. Improving the quality and developing health facilities with health personnel equally distributed throughout the country and
4. Improving community health through prevention and infectious disease control, health education and appropriate maternal and child health services, creating a healthy environment, improving nutritional status, and assuring clean water supply.

The government of Indonesia with their Safe Motherhood programs is committed to reduce maternal mortality rate (MMR) by 50% by the year 2000. By acceleration of different initiatives, e.g. revision of training programs for midwives and medical doctors, changes in the health service structure, policy and legislative changes and innovate interventions for reduction of maternal mortality. An initiative to update the curriculum of medical students and midwives and the method of competency-based training have been introduced to improve clinical skills of emergency, obstetric and neonatal health workers.

1. During pregnancy: Antenatal care and counseling

   During pregnancy, health workers should educate women about how to stay healthy during pregnancy; help women and families prepare for childbirth; and raise awareness about possible pregnancy complications and how to recognize and treat them. Health workers should also identify and manage any complications early and improve women's reproductive health and well-being through preventive measures (iron supplement, tetanus immunization) and by detecting and treating existing problems (such as STD)

2. During Childbirth: Skilled care during labor and delivery

   During childbirth, every women should be helped by a health professional who can manage a normal delivery as well as detect and manage complications such as hemorrhage, shock and infection. Skilled attendants should have access to a functioning emergency and transport system, so that they can refer women to an appropriate health facility centre for higher level medical care (such as Cesarean section or blood transfusion) if necessary.

3. After Delivery: Postpartum Care

   Following childbirth, women should be seen by a health worker, preferably within three days, so that any problems (such as infection) can be detected and managed early. An additional postpartum visit within the first six weeks after delivery enables health workers to make sure that the mother and baby are doing well, to provide advice and support for breastfeeding and to offer family planning (FP) information and services.

4. Before and After Pregnancy: Family Planning

5. Throughout the Reproductive Life Span: Abortion-related care

6. During Adolescence: Reproductive health education and services

7. For Women and Families: Community education

In order to prevent third-stage and postpartum hemorrhage, much research has been done and most of it reported that prophylactic administration of oxytocin 10IU in the third-stage of labor, as part of active management, prevents postpartum hemorrhage without increasing the incidence of retained placenta.

Texas obstetricians use oxytocin routinely in the management of third-stage of labor, but few are converted to active management. Oxytocin was the chosen oxytocic drug for routine third-stage management (95%) as well as for postpartum hemorrhage (73.3%)

Any oxytocic drug administered in the third-stage of labor reduces the blood loss of approximately 40% and hence the incidence of postpartum hemorrhage from 10 to 6%. Therefore, routine active management of third-stage of labor with an oxytocic drug is strongly recommended. Because of the few side-effects oxytocin is regarded as the best drug available at the moment.

Prophylactic administration of oxytocin or sulprostone directly after delivery followed by expectant management of third-stage will reduce postpartum blood loss and will shorten the duration of third-stage.

Incidence of postpartum hemorrhage was 5.9% in the active management group and 17.9% in the physiological group (odds ratio 3.13; 95% CI 2.3 to 4.2), a contrast reflected in other indices of blood loss. Apgar scores at one and five minutes and incidence of neonatal respiratory problems were not significantly different between the groups. When women allocated to active management (840) were compared with those who actually received physiological management (403), active management still produced lower rate of postpartum hemorrhage (odds ratio 2.4; 95% CI 1.6 to 3.7). As a conclusion of the study, policy of active management practiced in the trial leads to reduced incidence of postpartum hemorrhage, shortening of third-stage and reduced neonatal packed cell volume.

PURPOSE OF STUDY

1. Compare the impact on health provider's clinical skills after competency-based training on active management versus expectant management of normal delivery in basic maternal health care service.
2. Compare the influence of the training on the evidence of third-stage and postpartum hemorrhage.
3. Compare the influence of the normal delivery competency-based training with expectant management of third-stage of labor at the evidence of delivery complications, maternal and perinatal morbidity and mortality.

BENEFIT OF THE RESEARCH

1. To understand and have the experience of the advantage and disadvantage of active management of third-stage of labor regarding the evidence of postpartum hemorrhage and maternal and perinatal morbidity and mortality.
2. To provide a national standard clinical procedure in management of normal delivery with active management of third-stage of labor.

DESCRIPTION OF TERMS

• Spontaneous (normal) delivery is a process where the fetus and placenta were delivered by the mother's own force.
• Perinatal mortality is the total amount of stillbirths and early/neonatal death.
• Stillbirth is a dead-born baby after reaching 28 weeks of pregnancy or bodyweight more than 1000 grams.
• Early neonatal mortality is the death of an alive born baby after 7 days of delivery.
• Perinatal Mortality Rate is the total amount of fetal death during the perinatal period divided by the total amount of live deliveries.
• Live newborn delivery is the delivery of a conception or fetus, which is showing a sign of living (breath, heart beat and movement of vegetative muscles), without paying attention to the gestational age, before or after cutting of the umbilical chord and delivery of the placenta.
• Maternal mortality is maternal death during pregnancy, delivery and puerperium until 42 days after delivery, without paying attention to the gestational age, place of delivery and any management performed for terminating the pregnancy and not dealing with maternal death caused by accident or disaster.
• Maternal Mortality Rate (MMR) is the rate of maternal death in every 100,000 live deliveries.

CONCEPTUAL FRAMEWORK

Competency-based clinical skills training builds on each participant's past knowledge and takes advantage of his/her high motivation to accomplish the learning tasks in minimum time. Training emphasizes on practical aspects not just knowing, and uses competency-based evaluation of performance.

1. During the first day of the course, participants demonstrate their knowledge of management of normal delivery services by completing a written knowledge assessment (pre-course questionnaire). In addition, participants skills in taking patient's history, physical and basic obstetrics examination, and performing specific skills are assessed through role-play and use of a model which closely simulates the real situation in the human.
2. Classroom and clinic sessions focus on key aspects of service delivery (i.e. history of client, how to provide services and manage side-effects and other health problem)
3. Progress in knowledge-based competency is measured during the course using a written test (mid-course questionnaire).
4. Clinical skill training builds on each participant's previous normal delivery management experience. Participants first practice on the anatomical model. In this way, they will learn more quickly the skills needed for competently providing normal delivery services in clients.
5. Progress in learning new skills is documented using detailed history, basic physical and obstetric examination and clinical skills learning guides, while a competency-based evaluation of each participant's performance is conducted by the trainer during the course.

Successful completion of the course is based on passing both contents (knowledge and attitudes) and skills component (i.e. satisfactory performance on mid-course questionnaire and competency-based performance evaluation by the trainer).

There are opportunities for practicing in normal delivery services, as well as training in taking patient's history techniques, infection prevention, record keeping and postpartum follow-up of clients.

This consists in the skills necessary to undertake effective history. It would cover the characteristics of high-risk pregnancy and delivery, including the management of complication through health referral system and ways of maintaining good relations with the community.

This comprises high-risk pregnancy and delivery screening, the techniques for providing normal delivery management and management of complications and referral system.

This covers procurement, storage of supplies, care of the equipment, maintenance of aseptic conditions, organization of services, medical-record keeping and postpartum follow-up.

Approach to competency-based contraception method training

Because trainees may vary widely in experience and/or previous training, the length and content of normal delivery course and the clinical training activities involved in them will vary accordingly.

1. A reference manual containing only "need-to-know" information
2. A course handbook containing a validated (field-tested) questionnaire and learning guides that break down each activity or procedure into its essential components
3. Well-designed slide sets, video tapes and other teaching aids linked to the learning guides and to the information in the reference manual
4. Questionnaire and checklists for use in evaluating performance

Effective training will use these four essential elements to facilitate the learning process and foster competence in the task or activity.

Training in clinical skills should make as much use of teaching techniques that minimize risk to clients. For example, the use of well-designed visual aids and anatomical model rather than women for training at the skill acquisition and skill competency levels should be encouraged. Effective training with models facilitates learning and shorten training time, and is therefore an important factor in improving the quality of clinical skills training and minimizing risk to the client.

Table 1. Definition of the terms used to describe the different levels of clinical skills

As an example, before a new trainee attempts to help deliver the placenta using third-stage active management, the required skill and appropriate interactions with the woman should be demonstrated several times using pelvic model and/or appropriate training slide sets and video tapes. These should then be practiced repeatedly, using pelvic models and actual instruments and equipment under supervision in a setting that simulates reality as closely as possible.

The number of procedures that trainees observe, assist with and perform will vary depending on their background and skills and on the method of training.

In a recent study conducted for IUD insertion in Thailand, the traditional training method was compared with one in which models were used. Of trainees who used models, 70% were judged to be competent after only two insertion and 100% after six. By contrast, of the 150 trainees taught without the use of models, 50% achieved competency after 6 or 7 insertion and 10% did not do so even after 15.

Use of realistic anatomical models for training, not only for demonstration purposes, can reduce training time to 2 weeks or less, which represents a considerable saving in both time and cost.

In the Duke University, Durham NC USA, family practice residency programs have been designed on a rotation-based format. It has been assumed that by having residents rotating through a series of educational experiences, they would assimilate the skills necessary to effectively serve as a family physician. An alternative approach is based on the attainment of competency, rather than on the completion of a set of experiences. This method of education is known as competency-based education, mastery learning, or, more recently, outcomes-based assessment. Within family medicine there is a strong interest in the application of competency-based education to family practice residency training.

A study in Indonesia aimed to determine the learning curves and rapidity with which clinicians became competent to remove implants. Two Norplant removal techniques were used. Twenty-four physicians, none of whom were experienced in the use of Norplant implants were randomly assigned to learn either the new "U" removal or the standard technique. As a result, using competency-based training methods, the "U" removal technique was learned easily by inexperienced clinicians. It appears to offer significant improvements in speed and achievement of proficiency over the standard technique recommended by the manufacturer.

HYPOTHESIS

1. Using the competency-based normal delivery training will improve the service provider's clinical skills, thus lowering the evidence of pathological delivery, rate of complications and maternal/perinatal morbidity and mortality.
2. Third-stage active management will decrease the amount of third-stage hemorrhage and prevent the risk of postpartum hemorrhage after normal deliveries.
3. Third-stage active management will decrease the complication/risk on the third-stage of delivery.

METHODOLOGY

This is a randomized controlled trial including pregnant women with expected normal vaginal delivery by a competent health care provider who has received the competency-based normal delivery basic maternal health care training.

Women who fulfill the inclusion criteria will be selected randomly using a random table. Every woman who intends to deliver her baby at the birthing hut will be examined to assess the risk of pregnancy and delivery. If after thorough explanation of the advantages and disadvantages (if any) of the procedure and of possible alternatives the women agrees to participate, she will be asked to sign a written consent form. An open discussion of the research procedure will be performed with each woman.

Inclusion criteria

Every woman at the first-stage of delivery with a live intrauterine singleton pregnancy, at-term pregnancy, head presentation and predicted for a normal delivery.

Exclusion criteria

Predicted to be abnormal or high-risk pregnancies and deliveries caused by maternal with or without fetal anomaly.

The woman has the right to withdraw her consent at any time . In this case, she will be fully informed of any examination and management that has been done and other possible medical advice or alternatives for further delivery process.

1. Sample screening

Sample will be screened using form A.1 which is prepared for history and assessing the risk of pregnancy and delivery. High-risk pregnancy and delivery will be excluded from the study. Written informed consent will be obtained after thorough explanation.

2. Basic physical and obstetrics examination

Once the consent form has been signed, an additional examination will be performed to fulfill the inclusion criteria of the research using form A.2 which contains:

1. Physical examination
2. Obstetric examination
3. Determination of first-stage phase

3. Labor monitoring and evaluation

After fulfilling the inclusion criteria, a patient close monitoring and evaluation of the delivery process will be achieved using form B.1 which contains:

1. Partogram
2. Second-stage checklist, monitoring and evaluation
3. Third and forth-stage checklist, monitoring and evaluation
4. Neonatal checklist, monitoring and evaluation
5. First two-hours postpartum evaluation

4. Referred cases during labor

In case of problems occurring during delivery, which require access to a functioning emergency and transport system, the woman will be referred to an appropriate health facility centre for higher level medical care. Referred cases will be registered using form B.2 consisting of:

1. Diagnosis of referral
2. Rationalization of referral
3. Referral letter
4. Referral feedback form

5. Drop-out / research termination cases

In case the woman decides to withdraw her consent it will be registered using form C.1 stating:

1. The reason of termination
2. Management after termination.

Outcome measurement

Evaluation of the outcome of the basic maternal health care normal delivery training intervention will be based on:

1. amount of third-stage hemorrhage,
2. incidence of postpartum hemorrhage,
3. delivery complications and
4. evidence of maternal and neonatal nor perinatal morbidity and mortality

will be compared with the control group who has received expectant (physiological) third-stage management and baseline data before the training has been done.

Statistical analysis will be used for analyzing the data:

• Chi-square test and Student t-test for nominal and interval data
• Wilcoxon Matched - Pairs Signed - Ranks test for comparison of statistical significance
• Logistic regression and multivariate analysis
• Other statistical tests based on requirement for statistical significance calculation

RESEARCH ETHICS

Every woman who intended to deliver her baby at the birthing health facilities will be examined to assess of the risk of pregnancy and delivery. An informed consent will be obtained and disadvantages (if any) and other possible delivery alternatives will be explained by the health service. An open discussion of the research procedure will be performed with each woman. After giving information on the aim and benefit of the research, the woman will be asked to sign a consent form.

In the low risk group, both standardized management of normal delivery with expectant and active management of third-stage of labor was executed by a competent health care provider who has received the competency-based normal delivery basic maternal health care training. Normal delivery competency-based training package consists of high-risk pregnancy screening, management of first-stage pregnancy using a partogram, management of second-stage, third-stage active management and newborn care.

BASIC MATERNAL HEALTH CARE CLINICAL PROCEDURE - THIRD-STAGE ACTIVE MANAGEMENT

Bibliography

1. Maternal and Newborn Health / Safe Motherhood Unit, Family and Reproductive Health, World Health Organization. Care in Normal Birth: A Practical Guide. Geneva. 1996
2. Enkin M, Kein MJN, Chalmers I. A Guide to Effective Care in Pregnancy and Childbirth.
3. Hadijono RS, Waspodo D, Ahnan M, Asmuyeni (eds). Basic Maternal Health Care Training Package: Normal Delivery. POGI - JHPIEGO - Dep.Kes.RI. Jakarta. 1998
4. Khan GQ, John IS, Wani S, Doherty T, Sibai BM. Controlled cord traction versus minimal intervention techniques in delivery of the placenta: A randomized controlled trial. 11^th Annual Meeting of the Society of Perinatal Obstetricians. Anaheim. California. 1997
5. Adriaansz G, Hadijono RS. Third-stage Bleeding. ATS - NRC Surabaya Workshop. 1997
6. WHO Representative to Indonesia, "Citing Internet Sources". Report on the Progress of WHO Program.
7. Family Care International and the Safe Motherhood Inter-Agency Group (IAG). "Citing Internet Sources". Safe Motherhood Fact Sheet: The Safe Motherhood Initiative.
8. World Health Organization. Coverage of Maternal Care: A Listing of Available Information. 4^th edition. Geneva. 1997
9. Abu Dhabi third-stage trial: Oxytocin versus Syntometrine in the active management of third-stage of labour. Eur J Obstet Gynecol Reprod Biol 1995 Feb; 58(2): 147-151
10. Phillips CA, Kinch RA. Management of the third-stage of labor: a survey of practice among Texas obstetricians. Tex Med 1994 Dec; 90(12): 44-47
11. Van Dongen PW, Van Roosmalen J, De Boer CN, Van Rooij J. Oxytocics for the prevention of postpartum haemorrhages. A review. Pharm Weekbl [Sci] 1991 Dec 13; 13(6): 238-243
12. Poeschmann RP, Doesburg WH, Eskes TK. A randomized comparison of oxytocin, sulprostone nd placebo in the management of the third-stage of labour. Br J Obstet Gynaecol 1991 Jun; 98(6): 528-530
13. Prendiville WJ, Harding JE, Elbourne DR, Stirrat DM. The Bristol third-stage trial: active versus physiological management of third-stage of labour. BMJ 1988 Nov 19; 297(6659): 1295-1300
14. WHO. Model IUD training course. In: Intrauterine devices: Technical and managerial guidelines for services. Geneva. 1997 p.128-137
15. Ettington JE. The Winning Trainer. 2^nd edition. Houston TX. Gulf Publishing. 1989
16. JHPIEGO Corporation. IUD Course Handbook. Baltimore. 1992
17. Bell HS, Kozakowski SM, Winter RO. Competency-based education in family practice. Fam Med 1997 Nov;29(10): 701-4
18. Blumenthal PD, Gaffikin L, Affandi B, Bogiovanni A, McGrath J, Glew G. Training for Norplant implant removal: assessment of learning curves and competency. Obstet Gynecol 1997 Feb; 89(2):174-8

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