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Determinants of health-related quality of life in the postpartum period after obstetric complications
European Journal of Obstetrics & Gynecology and Reproductive Biology, pages 88 - 95
To determine the influence of socio-demographic, clinical parameters and obstetric complications on postpartum health-related quality of life (HRQoL).
We used data of three randomized controlled trials to investigate HRQoL determinants in women after an obstetric complication. The DIGITAT and HYPITAT trials compared induction of labor and expectant management in women with intra-uterine growth restriction (IUGR) and hypertensive disorders. The WOMB trial randomized anemic women after postpartum hemorrhage to red blood cell transfusion or expectant management. The HRQoL-measure Short-Form36 was completed at six weeks postpartum. Multivariable analyses were used to identify which parameters affected the Short-Form36 physical component score (PCS) and mental component score (MCS).
HRQoL analyses included 1391 women (60%) of the 2310 trial participants. HYPITAT and DIGITAT participants had significantly lower MCS than WOMB participants. In multivariable analysis, PCS after elective and emergency cesarean section was 5–6 points lower than after vaginal delivery. Gestational hypertension, neonatal admission and delivery in an academic hospital had a small negative effect on PCS. No effect was found for randomization status, maternal age, BMI, country of birth, education, parity, induction of labor, analgesics, birth weight, perineal laceration, delivery of placenta, postpartum hemorrhage, congenital anomaly, urinary tract infection, thromboembolic event or endometritis. MCS was influenced only mildly by these parameters.
IUGR and hypertensive disorders lead to lower HRQoL scores postpartum than PPH. In a heterogeneous obstetric population, only mode of delivery by cesarean section has a profound, negative impact, on physical HRQoL (PCS). No profound impacts on MCS were detected.
Keywords: Health-related quality of life, Obstetric labor complications, Postpartum period, Pregnancy complications.
Health-related quality of life (HRQoL) postpartum is potentially influenced by socio-demographic parameters, clinical parameters and obstetric complications. Socio-demographic parameters described to influence HRQoL postpartum negatively are black ethnicity  , low education  , low income  and large number of children at home  . A supportive social network influences postpartum HRQoL positively, , and . The influence of mode of delivery on HRQoL varies in literature though HRQoL seems either similar or compromised following cesarean section compared to vaginal delivery, , , , and . Common obstetric complications are intra-uterine growth restriction (IUGR), hypertensive disorders of pregnancy and postpartum hemorrhage (PPH), , and . Pregnancies with these complications are at increased risk for neonatal and/or maternal morbidity and mortality, , , and . Poor physical and mental health have been described in mothers with obstetric complications like preterm birth, , and . HRQoL is also compromised in women with postpartum complications like postpartum depression, , and , pregnancy-related deep vein thrombosis  and urinary and/or fecal incontinence, , , , and .
Recently, three multicenter trials were conducted that investigated maternal and/or neonatal outcomes and measured HRQoL in the postpartum period. The DIGITAT and HYPITAT trial primarily investigated the effect of induction of labor on neonatal and maternal outcome in pregnancies complicated by, respectively, IUGR and hypertensive disorders and . The WOMB trial primarily studied the effect of red blood cell transfusion (RBC) on physical fatigue in women after PPH  . The availability of such a large numbers of postpartum HRQoL data provided a unique opportunity to assess which parameters influence postpartum HRQoL after obstetric complications by combining data of the three trials.
We hypothesized that several socio-demographic and clinical parameters, as well as obstetric complications, affect postpartum HRQoL. Insight in these parameters will contribute to postpartum care and will provide the opportunity to develop individual strategies after obstetric complications.
Materials and methods
We used data of three randomized controlled trials, conducted within the Dutch Obstetric Consortium: the DIGITAT, HYPITAT and WOMB trial. Details of these studies and their ethic approval have been previously published, , and . In the DIGITAT, HYPITAT and WOMB trial 52, 38 and 37 Dutch hospitals participated, respectively. In each trial, women who refused randomization were asked to participate as non-randomized women. Results of the trials have been described elsewhere, , and .
The ‘Disproportionate-Intrauterine-Growth-Intervention-Trial-At-Term’ (DIGITAT) included women with a singleton pregnancy, a fetus in cephalic presentation, between 36 + 0 and 41 + 0 weeks gestational age, with suspected IUGR (defined as fetal abdominal circumference below the 10th percentile, estimated fetal weight below the 10th percentile and/or a decreased relative growth)  . Women were allocated to induction of labor or expectant management. Primary outcome was composite neonatal adverse outcome.
The ‘Hypertension-and-Preeclampsia-Intervention-Trial-At-Term’ (HYPITAT) included women with a singleton pregnancy, a fetus in cephalic presentation, between 36 + 0 and 41 + 0 weeks of gestation, complicated by gestational hypertension (defined as diastolic blood pressure ≥95 mmHg, measured on two occasions) or mild preeclampsia (defined as diastolic blood pressure ≥90 mmHg measured on two occasions, in combination with predefined levels of proteinuria)  . Again, women were allocated to induction of labor or expectant management. Primary outcome was a composite measure of maternal outcome.
The ‘Well-being of Obstetric patients on Minimal Blood transfusions’ (WOMB) studied women after PPH (defined as peripartum blood loss ≥1000 mL and/or decrease in Hb concentration ≥1.9 g/dL), with an Hb concentration between 4.8 and 7.9 g/dL (3.0–4.9 mmol/L) 12 to 24 h after delivery. Women were allocated to RBC transfusion or expectant management. Primary outcome was physical fatigue at day 3 postpartum, scored using the HRQoL measure multidimensional fatigue inventory.
Six hundred fifty-eight DIGITAT women (60%), 818 HYPITAT women (71%) and all WOMB women participated in the HRQoL study. Questionnaires were completed at several time points; the only common time point in the trials was six weeks postpartum. Each trial used the ShortForm-36 version 1 (SF-36v1), a generic HRQoL measure with eight scales (physical functioning, role limitations due to physical health problems [role-physical], bodily pain, general health, vitality, social functioning, role limitations due to emotional health [role-emotional], and mental health), ranging from 0 to 100; higher scores indicate better well-being. The SF-36v1 has been validated in a random nationwide sample of the Dutch population  . For this study, age and gender matched reference scores were provided by this research group (unpublished data based on 367 women aged 16–40 years, Aaronson et al.). The pilot study of the WOMB trial  provides postpartum reference scores based on 141 women that subsequently delivered in three Dutch hospitals.
The SF-36v1 allows for computation of the summary scores physical component score (PCS) and mental component score (MCS). These are norm-based with a mean of 50 and a standard deviation of 10, based on US population reference scores  . No Dutch population reference scores are available for the summary scores.
We studied the PCS and MCS at six weeks postpartum in women who suffered obstetric complications. To create a homogeneous cohort, women from the WOMB trial that delivered before 36 + 0 weeks of gestation and multiple gestations were excluded. We used multiple imputations to handle missing values of all socio-demographic and clinical parameters  : ten imputed data sets were created using a fully conditional specified model. Imputations were based on the relations between the covariates in the study. Data were analyzed separately in each imputed data set to obtain the effect estimates. Pooled estimates were generated from these ten imputed data sets and used to report estimates and their corresponding 95% confidence intervals.
SF-36v1 subscale scores were compared to Dutch population reference scores and to postpartum reference scores. As no Dutch population reference scores are available for the summary scores PCS and MCS, these were compared to US population references  .
We used univariable linear regression analysis to investigate parameters that were assumed to be related to HRQoL postpartum. The following socio-demographic and clinical parameters were analyzed: randomization status, age, BMI, country of birth (Dutch vs non-Dutch), highest education, parity, hypertensive disorders, gestational age at birth, induction of labor, analgesics, mode of delivery, perineal laceration, manual placenta removal, birth weight, PPH, admission of the neonate, congenital anomaly of the neonate, urinary tract infection, thrombo-embolic event, endometritis and hospital setting. To investigate the relationship of these parameters with HRQoL, we performed multivariable linear regression analysis, including those parameters with a significant relation to primary outcome measures in the univariable analyses (p < 0.10). Data were managed using SPSS version 20.0.
A total of 3191 women were included in the three trials. Fig. 1 shows the flowcharts of this study. A total of 2310 participated: 1399 (61%) were randomized while 911 women (39%) refused randomization but participated as non-randomized women. HRQoL data at six weeks postpartum were available in 1391 women as the response at this time point was 60% (61%, 65% and 55% in the DIGITAT, HYPITAT and WOMB trial, respectively). We will refer to responding women as responders while women with no HRQoL data at six weeks postpartum will be referred to as non-responders.
Socio-demographic and clinical parameters
The mean age of women was 30 years and 64% was primiparous. About 85% of women delivered vaginally, 46% had a hypertensive disorder while 41% suffered from a PPH. Among our study population, one maternal death occurred. This patient, allocated to induction of labor in the DIGITAT trial, died at home 10 days after delivery. A cause for her death could not be found. Furthermore, one perinatal death occurred in the DIGITAT trial, among the non-randomized women.
Table 1 shows socio-demographic and clinical parameters and the differences between responders and non-responders. Compared to non-responders, responders were significantly older, more frequently born in The Netherlands and had a higher education. Also, differences were found in clinical parameters like parity, perineal laceration, rate of hypertensive disorders and rate of PPH.
|Total||Responders||Non-responders||p-Value responders vs non-responders|
|n = 2310||n = 1391||n = 919|
|Maternal age in years, mean (SD)||29.9 (5.2)||30.5 (4.9)||28.9 (5.5)||<0.001|
|Missing, n (%)||7 (0.3%)||2 (0.1%)||5 (0.5%)|
|<18.5||98 (4%)||59 (4%)||39 (4%)|
|18.5–25||1168 (51%)||698 (50%)||470 (51%)|
|>25||763 (33%)||483 (35%)||280 (31%)|
|Missing||281 (12%)||151 (11%)||130 (14%)|
|Country of birth (%)||<0.001|
|Dutch||1838 (80%)||1199 (86%)||639 (70%)|
|Non-Dutch||287 (12%)||111 (8%)||176 (19%)|
|Missing||185 (8%)||81 (6%)||104 (11%)|
|None/primary education||178 (8%)||91 (7%)||87 (10%)|
|Secondary education||848 (37%)||506 (36%)||342 (37%)|
|Higher professional education/university||520 (23%)||376 (27%)||144 (16%)|
|Missing||764 (33%)||418 (30%)||346 (38%)|
|Parity, n %||0.004|
|Primiparous||1476 (64%)||922 (66%)||554 (60%)|
|Multiparous||834 (36%)||469 (34%)||365 (40%)|
|None||1298 (56%)||747 (54%)||551 (60%)|
|Gestational hypertension||619 (27%)||412 (30%)||207 (23%)|
|Preeclampsia||373 (16%)||225 (16%)||148 (16%)|
|Missing||20 (1%)||7 (0.5%)||13 (1%)|
|Gestational age, mean (SD)||39 + 4 (10)||39 + 4 (10)||39 + 4 (10)||0.16|
|Induction of labor||1300 (56%)||822 (59%)||478 (52%)||<0.001|
|None||964 (42%)||554 (40%)||410 (45%)|
|Missing||46 (2%)||15 (1%)||31 (3%)|
|Mode of delivery||0.003|
|Vaginal, spontaneous||1590 (69%)||966 (69%)||624 (68%)|
|Vaginal, operative||346 (15%)||227 (16%)||119 (13%)|
|Elective CS||57 (3%)||26 (2%)||31 (3%)|
|Emergency CS||317 (14%)||172 (12%)||145 (16%)|
|Cephalic||2250 (97%)||1364 (98%)||886 (96%)|
|Other position||20 (1%)||11 (1%)||9 (1%)|
|Missing||40 (2%)||16 (1%)||24 (3%)|
|None||1298 (56%)||818 (59%)||480 (52%)|
|Opiates||288 (13%)||165 (12%)||123 (13%)|
|Epidural/spinal||593 (26%)||343 (25%)||250 (27%)|
|General anesthesia||13 (0.6%)||5 (0.4%)||8 (1%)|
|Missing||118 (5%)||60 (4%)||58 (6%)|
|<10th percentile||596 (26%)||362 (26%)||234 (26%)|
|10–90 percentile||1418 (61%)||856 (62%)||562 (61%)|
|>90 percentile||266 (12%)||165 (12%)||101 (11%)|
|Missing||30 (1%)||8 (0.6%)||22 (2%)|
|None or first degree a||1069 (46%)||605 (44%)||464 (51%)|
|Second degree or higher||1228 (53%)||781 (56%)||447 (49%)|
|Missing||13 (0.6%)||5 (0.4%)||8 (1%)|
|Academic||644 (28%)||367 (26%)||227 (30%)|
|Teaching||1563 (68%)||954 (69%)||609 (66%)|
|Non-teaching||103 (5%)||70 (5%)||33 (4%)|
|Spontaneous a||1990 (86%)||192 (14%)||124 (14%)|
|MPV or curettage||316 (14%)||1195 (86%)||795 (87%)|
|Missing||4 (0.2%)||4 (0.3%)||0|
|PPH, n %||940 (41%)||523 (38%)||417 (45%)||0.001|
|No||1339 (58%)||849 (61%)||490 (53%)|
|Missing||31 (1%)||19 (1%)||12 (1%)|
|RBC transfusion||386 (17%)||224 (16%)||162 (18%)||<0.001|
|No RBC transfusion||1379 (60%)||873 (63%)||506 (55%)|
|Missing||545 (24%)||294 (21%)||251 (27%)|
|Neonatal admission, n %||1240 (54%)||764 (55%)||476 (52%)||0.32|
|No neonatal admission||1066 (46%)||625 (45%)||441 (48%)|
|Missing||4 (0.2%)||2 (0.1%)||2 (0.2%)|
|Congenital anomaly (severe)||22 (1%)||12 (1%)||10 (1%)||0.74|
|None||2288 (99%)||1379 (99%)||909 (99%)|
|Urinary tract infection||47 (2%)||27 (2%)||20 (2%)||<0.001|
|No urinary tract infection||2058 (89%)||1280 (92%)||778 (85%)|
|Missing||205 (9%)||84 (6%)||121 (13%)|
|Thrombo-embolic event||6 (0.3%)||4 (0.3%)||2 (0.2%)||<0.001|
|No thrombo-embolic event||2100 (91%)||1301 (94%)||799 (87%)|
|Missing||204 (9%)||86 (6%)||118 (13%)|
|Endometritis||21 (1%)||11 (1%)||10 (1%)||<0.001|
|No endometritis||2086 (90%)||1296 (93%)||790 (86%)|
|Missing||203 (9%)||84 (6%)||119 (13%)|
a Including cesarean sections.
BMI—body mass index, CS—cesarean section, PPH—postpartum hemorrhage, MPV—manual placenta removal, RBC—red blood cell.
Health-related quality of life
Table 2 demonstrates the SF-36v1 scores (total and per trial) and available reference scores. Fig. 2 presents the PCS and MCS per trial. Maximal differences between trials for these summary scores were 4.6 and 3.2 points, respectively (bothp-values <0.001). Women in the WOMB trial had higher PCS and MCS than women in the HYPITAT and DIGITAT trial; though only the differences in MCS were significant (p-values for the difference in MCS 0.01 and <0.001, respectively).
|This study, Total||This study, DIGITAT||This study, HYPITAT||This study, WOMB||Dutch population reference ||Postpartum reference |
|N||Mean (SD)||N||Mean (SD)||N||Mean (SD)||N||Mean (SD)||Mean (SD)||Mean (SD)|
|PCS||1364||46 (9)||393||45 (10)||526||44 (9)||445||48 (9)||NA||NA|
|MCS||1364||53 (9)||393||51 (10)||526||52 (9)||445||54 (8)||NA||NA|
|Physical functioning||1383||86 (17)||403||86 (18)||528||85 (16)||452||86 (17)||92 (13)||85 (19)|
|Role-physical||1379||60 (42)||401||57 (42)||528||50 (42)||450||73 (38)||86 (29)||74 (37)|
|Bodily pain||1385||61 (28)||401||77 (19)||528||54 (25)||456||73 (28)||79 (19)||78 (28)|
|General health||1379||78 (18)||398||76 (19)||527||78 (17)||454||79 (18)||77 (17)||78 (18)|
|Vitality||1382||60 (18)||401||57 (18)||527||57 (17)||454||66 (18)||68 (16)||68 18)|
|Social functioning||1386||78 (23)||402||75 (25)||528||75 (23)||456||84 (20)||86 (19)||86 (19)|
|Role-emotional||1379||84 (33)||399||82 (34)||528||83 (33)||452||85 (32)||82 (33)||83 (34)|
|Mental health||1382||82 (15)||401||79 (16)||527||80 (15)||454||86 (15)||76 (15)||86 (14)|
SF-36v1—36-item short form, PCS—physical component score, MCS—mental component score, NA—not available.
No Dutch references for the summary scores were available. However, US population reference scores for the PCS and MCS, with a mean of 50 and a standard deviation of 10, are previously published  .
For SF-36v1 subscales, Dutch population reference scores, matched for both gender and age, were made available by Aaronson et al. (unpublished data, the Materials and methods section)  .
Also, postpartum reference scores are presented; these scores were derived from the pilot study of the WOMB trial  .
With regard to the SF-36v1 summary scores, the average PCS in our study population was 4 points lower than the US population reference score and while the average MCS in our study was 3 points higher (bothp-values <0.001).
Dutch population reference scores for the SF-36v1 subscales were made available for women aged from 16 to 40 years (unpublished data, see the Materials and methods section). Average general health and role-emotional scores in our study were comparable to these reference scores (p = 0.04 andp = 0.053, respectively) while the mental health score in our study was six points higher (p < 0.001). The remaining subscales in our study population had lower average scores than their Dutch reference (allp-values <0.001). Largest differences between subscale scores in our study and Dutch population reference scores were found for the subscales role-physical and bodily pain (26 and 18 points, respectively).
Comparing scores in our study to postpartum reference scores demonstrated that all SF-36v1 subscale scores in our study had a lower average (allp-values <0.001), except for the subscales physical functioning and role-emotional that were similar, and general health that was equal. Again, largest differences were found for the subscales role-physical and bodily pain (14 and 17 points, respectively).
Results of the univariable analyses are tabulated in Online Resource 1. Following these analyses, multivariable regression analyses were performed to assess the influence of socio-demographic and clinical parameters on PCS and MCS. Gestational hypertension, elective cesarean section, emergency cesarean section, neonatal admission and delivery at an academic hospital were negatively related to PCS ( Table 3 ): the PCS was on average 1.5 points lower in women with gestational hypertension, 1.3 points lower in case of neonatal admission, 1.2 points lower after delivery at an academic hospital and, respectively, 5.6 and 6.3 points lower after elective or emergency cesarean section. As demonstrated in Table 3 , the MCS was found to be influenced negatively by a foreign country of birth (1.9 points lower) and induction of labor (1.4 points lower) while the score of women who had had a PPH was 1.8 points higher than the score of women who had not suffered PPH.
|Physical component score||Mental component score|
|Country of birth|
|Higher professional education/university||0.874||0.634||0.17||−0.034||0.592||0.95|
|Induction of labor|
|Mode of delivery|
|None or first degree a||Ref||Ref|
|Second degree or higher||−0.345||0.608||0.58||0.669||0.513||0.19|
|MPV or curettage||−0.473||0.809||0.56||−0.580||0.814||0.48|
|Congenital anomaly (severe)|
a Including cesarean sections.
BMI—body mass index, CS—cesarean section, MPV—manual placenta removal, PPH—postpartum hemorrhage.
Determinants of postpartum HRQoL after obstetric complications were investigated. We found that women with pregnancies complicated by IUGR and hypertensive disorders overall had lower mental HRQoL scores than PPH. Gestational hypertension, delivery by cesarean section, neonatal admission and delivery in an academic hospital were found to be negatively related to PCS in this study. The impact of a cesarean section was the largest. MCS was, only mildly, influenced by foreign country of birth, induction of labor and PPH.
For the interpretation of results, it is important to realize that a significant difference in HRQoL score does not necessarily indicate that this difference is meaningful. The magnitude of the difference determines whether the difference is of clinical importance. Estimates of the minimal clinical important change in the scores PCS and MCS vary from 5 to 10  . This implies that the differences in average scores between trials, as found in this study, were relatively small. Also, all effects on PCS and MCS seem small, except for the negative influence of mode of delivery by cesarean section on PCS: after elective and emergency cesarean section women scored on average 6 points lower than after spontaneous vaginal delivery. Consequently, only mode of delivery seems to have a profound impact on HRQoL postpartum.
The finding that women after PPH were found to have a relatively high MCS was unexpected. All women in our study suffered from an obstetric complication and PPH apparently had a relatively positive effect in comparison to the other complications (IUGR and hypertensive disorders).
Compared to US-based population  , our study population demonstrated overall lower PCS though higher MCS. Furthermore, our population had on average lower scores on all subscales, except for general health, role-emotional and mental health, compared to Dutch reference scores (unpublished data, provided by Aaronson et al.)  . Presumably physical HRQoL is suboptimal after delivery and even worsened by obstetric complications; while mental HRQoL is most likely positively influenced by new motherhood.
Our population had significantly lower scores on all subscales than the postpartum reference scores demonstrated in Table 2  , except for physical functioning and role-emotional (similar) and general health (equal). The obstetric complications that our study population suffered from, presumably account for these differences.
Factors associated with HRQoL as described in previous literature like ethnicity, education, and preterm birth were not be confirmed in this study. However, HRQoL scores might already have normalized to a large extent at six weeks postpartum: findings in this study and the pilot study indicate that measuring SF-36v1 scores at one or two additional time points (earlier than six weeks postpartum) might have been very informative  . Previous literature regarding the influence of mode of delivery on HRQoL is contradictive. Of previous studies that used the ShortForm-36, two studies demonstrated similar results, one study found better HRQoL following a cesarean section than following vaginal delivery and one study described no influence of mode of delivery on physical HRQoL, , , and . These studies however, were based on much smaller populations. Two studies that used different HRQoL measures did not find lower HRQoL after a cesarean section and . Although numbers in these studies were relatively large (n > 1000), results cannot be compared due to the different measurement methods.
The selection of women with an obstetric complication in this study should be taken into consideration. Another limitation of this study is the use of combined data collected in three randomized controlled trials, although no effect of randomization on postpartum HRQoL was detected. Also, no treatment effect on HRQoL was found in women randomized to induction of labor or expectant management in the DIGITAT and HYPITAT trial and while in WOMB trial differences in HRQoL between study groups were small at six weeks postpartum  . The effect of randomization and treatment strategy on our results seems therefore minimal. Many differences between responders and non-responders were found. These were partly predictable, as socio-demographic differences like age, ethnicity and education are parameters known to influence response rates  . Due to the large numbers many differences were significant even when the magnitude of the difference was small.
The major strengths of this study are the nationally collected data and the large numbers.
In a heterogeneous obstetric population, delivery by elective and emergency cesarean section are the only factors that have a profound, negative impact on physical HRQoL. No profound impacts on mental HRQoL were detected. Of the studied obstetric complications, PPH seems to influence postpartum HRQoL less than IUGR and hypertensive disorders. These results emphasize the need for careful consideration while determining mode of delivery and bring in reliable information to support discussions about (determinants of) HRQoL after obstetric complications.
Fetal growth restriction and hypertensive disorders lead to lower health-related quality of life scores postpartum than postpartum hemorrhage. In a heterogeneous obstetric population, only mode of delivery by cesarean section has a profound, negative impact, on the physical health-related quality of life.
Conflict of interest statement
We commit that we did not get any financial, consulting, and personal relationships with other people or organizations that could influence our work.
We would like to thank the research nurses, midwives and secretaries of our consortium, the staff of all participating centers, and the women who participated in the trials for their contributions.
The HYPITAT and DIGITAT trial were funded by ZonMw (grant number 945-06-553 and 945-04-558, respectively). The WOMB trial was funded by the Landsteiner Foundation for Blood Transfusion Research (grant number 0904) and Stichting Vrienden van de Bloedtransfusie (grant number 1201.005). Study sponsors had no involvement in collection, analysis and interpretation of data and in the writing of the manuscript.
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a Department of Obstetrics and Gynecology, Erasmus Medical Centre, Rotterdam, The Netherlands
b Department of Obstetrics and Gynecology, Maasstad Hospital, Rotterdam, The Netherlands
c Department of Public Health, Academic Medical Centre, Amsterdam, The Netherlands
d Sanquin Blood Supply Foundation, Rotterdam, The Netherlands
e Department of Obstetrics and Gynecology, Bronovo Hospital, Den Haag, The Netherlands
f Department of Obstetrics and Gynecology, University Medical Centre Groningen, Groningen, The Netherlands
g Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
h School of Pediatrics and Reproductive Health, University of Adelaide, Adelaide 5000 SA, Australia
☆ Data of this study were collected in trials that were conducted in a total of 52 hospitals in The Netherlands.
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