Project description

Academic title and name: MD, Anne Raabjerg Kruse

Project title: Fast-track discharge after elective cesarean section

Objective

The aim is to evaluate fast-track discharge for multiparas after elective cesarean section (CS) concerning neonatal and maternal complications as well as the parents’ sense of security.

Background

The CS rate has increased considerably to more than 20% (1) and is thus conducted more than 10,000 times yearly in Denmark. During the last 20 years, the time of hospitalization after CS has decreased from a week to two or three days and new developments in management of pain may allow for discharge to home even earlier, e.g. within 6 – 24 hours.

The economic consequences of early discharge may be substantial. Other aspects, however, must be considered.

The risk of major postoperative hemorrhage (POH) after discharge is of major concern. It remains, however, to be established whether women without clinical signs of bleeding six hours after CS are of reasonable low risk of POH to allow for early discharge. We know that POH occurs with a rate of about 2% (2). A retrospective study indicated that active bleeding with need for reoperation is diagnosed within 12 hours but the study sample was small and did not allow for safe conclusions (3). Proper data on the risk of postoperative bleeding and the time of diagnosis are therefore needed before introduction of fast-track CS.

The incidence and the timing of fetal problems with need of professional neonatal care should likewise be considered. A recent Danish study indicated an overall risk of admission to neonatal care of more than 10% after elective CS (4), but data on the time of diagnosis were not given. Further information on this aspect is therefore needed as well.

Delivery by CS implies a higher risk of early breastfeeding cessation compared to vaginal delivery (5,6). Access to experienced staff is therefore a central element of postoperative care and this might be jeopardized by early discharge. A home visit the day after discharge combined with access to a health professional from the postnatal ward 24 hours a day within the first 72 hours might solve this problem, but firm data are needed to substantiate this hypothesis. The sense of security for both the mother and father represent another important issue of early discharge versus standard hospital stay (7-9).

One recent randomized controlled trial study from Malaysia indicated CS with discharge after 24 hours is associated with equal patient’s satisfaction compared to discharge after 48 hours (10). The validity of these data in a Danish context is limited by differences in health care system and possibly also attitude of the patients. Patients’ sense of security therefore remains uncertain and need further investigation.

Taken together, the incidence of maternal and fetal neonatal problems and the time of diagnosis should be evaluated before fast track CS is introduced. With this reservation, introduction of effective pain treatment might level out the difference between CS and vaginal delivery. This could make early discharge possible, with potential benefits for the family provided sufficient outpatient support but patients’ sense of security and satisfaction remains an important issue. A randomized controlled comparison of early versus standard discharge should therefore be performed to evaluate these aspects of the two regimens.

Part 1

Aim

  • We want to evaluate at what time after an elective cesarean section the clinical signs of a complication occur in the mother or the newborn.
  • We want to evaluate whether these complications occur primarily in mothers and newborns characterized by certain risk factors.

Perspective

We believe that these results will give us important information concerning planning a safe time after the cesarean section to send home the mother and the newborn.

Materials and methods

Study design

Historical cohort study. Register-based.

Databases

The Aarhus Birth cohort (ABC) includes a cohort of more than 100,000 deliveries at Aarhus University Hospital from 1989 to 2012 (11). Research-midwifes validated the data, which include information about the pregnancy, delivery, complications and readmissions during the first post partal week. Furthermore, the database include information about the child regarding complications and transfer to neonatal ward.

The National Birth Register includes information regarding complications and readmissions for both mother and child during the first 28 days.

Study-population

  • Women undergoing elective cesarean section included in the ABC between 1989 and 2012.
  • Newborns to these women.

Cases

  • Participants who needed operation or blood transfusion within 28 days after the cesarean section.
  • Newborns transferred to the neonatal intensive care unit within 28 days after the cesarean section.

Controls

  • Participants not characterized as cases.

Variables

Background variables for the entire study-population: BMI, smoking status, parity, plurality, number of CS, indication of the CS, birth weight of the child, and perioperative bleeding.

Cases will have their files scrutinized with focus at the status after 12, 24, 36, and 48 hours concerning clinical signs of the complication which characterize the participant as a case.

Part 2

Primary hypothesis

  • Discharge 24-28 hours after CS compared to inpatient care for at least 48 hours does not influence the parents’ postnatal sense of security measured by a postnatal sense of security questionnaire (PPSS) (12).

Secondary hypotheses

  • Postoperative use of analgesia is decreased by discharge 24-28 hours after elective CS compared to inpatient care for at least 48 hours.
  • Postoperative mobilization is improved by discharge 24-28 hours after elective CS compared to inpatient care for at least 48 hours.
  • The rate of readmissions is not affected by discharge 24-28 hours after elective CS compared to inpatient care for at least 48 hours.
  • Duration of breastfeeding is not affected by discharge 24-28 hours after elective CS compared to inpatient care for at least 48 hours.

Materials and methods

Study design

A randomized controlled trial will be performed including 142 women allocated to either discharge 24-28 hours after elective CS or standard discharge after at least 48 hours.

Setting and participants

Multiparous women having an elective CS at the Department of Obstetrics at Herning Hospital, Denmark between November 2015 and November 2017. The Department of Obstetrics is a specialized unit with about 2700 deliveries annually. In 2012 a total number of 500 CS were performed, of which 243 were elective.

Inclusion criteria

  • Planned elective CS of multiparous women
  • Singleton pregnancy
  • Age of at least 18
  • Gestational age 37+0 to 41+6 weeks

Exclusion criteria

  • Lack of consent
  • Women with no or little understanding of and ability to speak Danish.
  • Expected maternal or neonatal complications after delivery

Description of the Study

The woman is recruited to the project by the obstetrician at the outpatient clinic when the decision about an elective CS is taken. All women who meet the inclusion criteria are asked to participate together with their partner after detailed information.Participating women will be allocated to either discharge after 24-28 hours or discharge after at least 48 hours by an external computer randomization.

Women in both groups follow the same procedures at the day of CS. The woman is referred to the operating room where a single shot spinal block is applied for anaesthesia. After the delivery the women are referred directly to the postnatal ward. The standard analgesia treatment in both groups consists of an intravenous injection of 30 mg NSAID and 10 mg morphine orally when arriving at the postnatal ward after the delivery. After 3 hours, 10 mg morphine orally, is repeated. Furthermore, paracetamol retard (2 g twice a day) and naproxen (500 mg twice a day) is used. Morphine orally (10 mg) or intravenous (5 mg) is used when needed.

Women allocated to fast-track discharge are expectedly discharged after 24-28 hours with possibility of outpatient care including a home visit from the postnatal ward by a nurse or a midwife within the first 72 hours. Before discharge a health care professional makes sure that the mother and infant meet the hospital discharge criteria (13).

Primary outcome

  • The parents’ postnatal sense of security in the first week after delivery is measured by the postnatal sense of security questionnaire.

Secondary outcomes

  • Pain scores, use of analgesia and mobilization measured by an activity monitor (Fitbit Flex) will be registered by the patients during the first week in a diary.
  • Readmissions and contacts to the hospital concerning both the mother and her child during the first 28 days will be registered.
  • Duration of breastfeeding registered in a questionnaire sent to the woman 6 months after discharge.

Statistical aspects

The sample size calculation is based on the primary outcome measure of the study, parents’ postnatal sense of security (PPSS) (14). There do not appear to be any data on patient satisfaction and fast-track CS. We want to detect a difference of three on the PPSS scale that has a standard deviation of six, which we believe will be clinically significant. To detect this difference with 80% power and 5% significance level we need 64 women in each group. With drop-out in mind we increase this sample size by 10% in each group, which means a total of 142 women.

Ethical aspects

The study is approved by the regional Etichs Committee in Central Denmark and by the Danish Data Protection Agency. First part of the study is based on existing information from a regional and national register, and hence the study will not add any additional burden to the women or the children. In the second part of the study the woman and her partner participate after informed consent, and refusal to participate will in no way influence their care. The parents, participating in the study, can at any time withdraw without any consequences’ for them and if there will be any complications after return to home, the woman and her child are readmitted immediately at the postnatal ward. The study will be registered at ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.

Responsibilities

Anne Raabjerg Kruse, MD, Department of Gynecology and Obstetric, Herning, is responsible for collecting the data, written material to the patients, analyses of data, and writes the drafts on the studies.

Axel Forman, Professor, DMsc, Department of Obstetrics andGynecology, Aarhus University Hospital, Skejby, is, as professor in operative gynecology, the main supervisor of the entire project.

Niels Uldbjerg, Professor, DMSc, Department of Obstetrics and Gynecology, Aarhus University Hospital, Skejbyis the obstetrical co-supervisor on the entire project.

Ulrik Schiøler Kesmodel, MD, Honorary Associate Professor, Department of Obstetrics and Gynecology, Aarhus University Hospital, Skejby, is the epidemiological co-supervisor on the entire project.

Finn Friis Lauszus, MD, Assistant Professor, Ph.D, Department of Gynecology and Obstetrics, Herning is the local source at the department and the daily co-supervisor on the entire project.

Tine Brink Henriksen, MD, Professor, Ph.D, Department of Pediatrics, Aarhus University Hospital, Skejby, is member of the steering committee, responsible for The Aarhus Birth cohort and the expert in neonatology on the project.

Carsten Byrjalsen, MD, Chief Consultant, Department of Gynecology and Obstetrics, Herning, is member of the steering committee of the project and the liaison person to other departments.

Perspectives

This study will be among the first evaluating fast-track discharge after CS in a European context, and will provide important data on the benefits and limitations of this regimen after CS. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.

References

(1) Statens Serum Institut. Fødselsstatistikken. 2012; Available at: Accessed 3/13, 2014.

(2) Holm C, Langhoff-Roos J, Petersen KB, Norgaard A, Diness BR. Severe postpartum haemorrhage and mode of delivery: a retrospective cohort study. BJOG 2012 Apr;119(5):596-604.

(3) Lurie S, Sadan O, Golan A. Re-laparotomy after cesarean section. Eur J Obstet Gynecol Reprod Biol 2007 Oct;134(2):184-187.

(4) Glavind J, Kindberg SF, Uldbjerg N, Khalil M, Moller AM, Mortensen BB, et al. Elective caesarean section at 38 weeks versus 39 weeks: neonatal and maternal outcomes in a randomised controlled trial. BJOG 2013 Aug;120(9):1123-1132.

(5) Prior E, Santhakumaran S, Gale C, Philipps LH, Modi N, Hyde MJ. Breastfeeding after cesarean delivery: a systematic review and meta-analysis of world literature. Am J Clin Nutr 2012 May;95(5):1113-1135.

(6) Zanardo V, Svegliado G, Cavallin F, Giustardi A, Cosmi E, Litta P, et al. Elective cesarean delivery: does it have a negative effect on breastfeeding? Birth 2010 Dec;37(4):275-279.

(7) Persson EK, Dykes AK. Important variables for parents' postnatal sense of security: evaluating a new Swedish instrument (the PPSS instrument). Midwifery 2009 Aug;25(4):449-460.

(8) Persson EK, Fridlund B, Kvist LJ, Dykes AK. Fathers' sense of security during the first postnatal week--a qualitative interview study in Sweden. Midwifery 2012 Oct;28(5):e697-704.

(9) Persson EK, Dykes AK. Parents' experience of early discharge from hospital after birth in Sweden. Midwifery 2002 Mar;18(1):53-60.

(10) Chiong Tan P, Jin Norazilah M, Zawiah Omar S. Hospital discharge on the first compared with the second day after a planned cesarean delivery: a randomized controlled trial. Obstet Gynecol 2012 Dec;120(6):1273-1282.

(11) Larsen PS, Kamper-Jorgensen M, Adamson A, Barros H, Bonde JP, Brescianini S, et al. Pregnancy and birth cohort resources in europe: a large opportunity for aetiological child health research. Paediatr Perinat Epidemiol 2013 Jul;27(4):393-414.

(12) Persson EK, Fridlund B, Dykes AK. Parents' postnatal sense of security (PPSS): development of the PPSS instrument. Scand J Caring Sci 2007 Mar;21(1):118-125.

(13) e-dok.rm.dk. 2.10.1.1 Observation af indlagte voksne patienter, (TOKS) HEV. 2011; Available at: Accessed 3/24, 2014.

(14) Kvist LJ, Persson EK. Evaluation of changes in postnatal care using the "Parents' Postnatal Sense of Security" instrument and an assessment of the instrument's reliability and validity. BMC Pregnancy Childbirth 2009 Aug 12;9:35-2393-9-35.

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