Catalogue Search | MBRL
Search Results Heading
Explore the vast range of titles available.
MBRLSearchResults
-
DisciplineDiscipline
-
Is Peer ReviewedIs Peer Reviewed
-
Item TypeItem Type
-
SubjectSubject
-
YearFrom:-To:
-
More FiltersMore FiltersSourceLanguage
Done
Filters
Reset
27
result(s) for
"Bergholt, Thomas"
Sort by:
Maternal age and body mass index and risk of labor dystocia after spontaneous labor onset among nulliparous women: A clinical prediction model
by
Gam, Christiane Bourgin Folke
,
Hegaard, Hanne Kristine
,
Bergholt, Thomas
in
Adult
,
Algorithms
,
Births
2024
Obstetrics research has predominantly focused on the management and identification of factors associated with labor dystocia. Despite these efforts, clinicians currently lack the necessary tools to effectively predict a woman's risk of experiencing labor dystocia. Therefore, the objective of this study was to create a predictive model for labor dystocia.
The study population included nulliparous women with a single baby in the cephalic presentation in spontaneous labor at term. With a cohort-based registry design utilizing data from the Copenhagen Pregnancy Cohort and the Danish Medical Birth Registry, we included women who had given birth from 2014 to 2020 at Copenhagen University Hospital-Rigshospitalet, Denmark. Logistic regression analysis, augmented by a super learner algorithm, was employed to construct the prediction model with candidate predictors pre-selected based on clinical reasoning and existing evidence. These predictors included maternal age, pre-pregnancy body mass index, height, gestational age, physical activity, self-reported medical condition, WHO-5 score, and fertility treatment. Model performance was evaluated using the area under the receiver operating characteristics curve (AUC) for discriminative capacity and Brier score for model calibration.
A total of 12,445 women involving 5,525 events of labor dystocia (44%) were included. All candidate predictors were retained in the final model, which demonstrated discriminative ability with an AUC of 62.3% (95% CI:60.7-64.0) and Brier score of 0.24.
Our model represents an initial advancement in the prediction of labor dystocia utilizing readily available information obtainable upon admission in active labor. As a next step further model development and external testing across other populations is warranted. With time a well-performing model may be a step towards facilitating risk stratification and the development of a user-friendly online tool for clinicians.
Journal Article
Low‐Dose Prophylactic Oral Iron Supplementation (Ferrous Fumarate, Ferrous Bisglycinate, and Ferrous Sulphate) in Pregnancy Is Not Associated With Clinically Significant Gastrointestinal Complaints: Results From Two Randomized Studies
by
Bergholt, Thomas
,
Milman, Nils Thorm
in
Administration, Oral
,
Adult
,
Anemia, Iron-Deficiency - prevention & control
2024
Background: Many pregnant women are reluctant to follow the recommendation concerning oral iron prophylaxis due to concerns about gastrointestinal (GI) side effects. Objective: To assess the frequency of GI complaints during low‐dose oral iron prophylaxis and compare three iron formulas in equipotent doses: ferrous fumarate versus ferrous bisglycinate versus ferrous sulphate, in healthy women with an uncomplicated single pregnancy. Methods: Results from two randomized, double‐blind studies are reported: the Gentofte study comprising 404 women allocated into four groups taking 20, 40, 60, and 80 mg of elemental iron as ferrous fumarate/day and the Naestved study comprising 78 women allocated into two groups: 25 mg of elemental iron as ferrous bisglycinate/day and 50 mg of elemental iron as ferrous sulphate/day between meals from 15 to 19 weeks of gestation to delivery. GI complaints (nausea, vomiting, epigastric pain/pyrosis, belching, meteorism, borborygmi, intestinal colic, flatulence, loose stools, constipation, and use of laxatives), as well as black stools, were recorded by interview at the time of inclusion and at regular intervals during gestation. Results: At inclusion, the frequency of total combined GI complaints in all women ( n = 482) was 21%. The Gentofte study showed that in the groups taking 20–60 mg iron/day as fumarate, there was no association between the iron dose and the frequency of GI side effects. An iron dose of 80 mg as fumarate was associated with significantly higher frequencies of constipation and the use of laxatives. Comparing the three equipotent doses of iron formulas, which can prevent iron deficiency, ferrous bisglycinate 25 mg iron had the most favourable GI side effect profile, while ferrous fumarate 40 mg iron and ferrous sulphate 50 mg iron had higher but similar GI side effect profiles. The frequency of black stools increased with the iron dose. Ferrous bisglycinate 25 mg iron had a lower frequency of black stools (8%) than ferrous fumarate 40 mg iron (22%) and ferrous sulphate 50 mg iron (31%). Conclusion: Low‐dose iron supplementation appears to have no clinically significant GI side effects, as none of the included women presented with GI complaints of such severity that it necessitated either reduction of iron dose, change to an alternative iron formula, or discontinuation of iron supplement. However, ferrous bisglycinate 25 mg iron/day is associated with significantly fewer GI complaints than ferrous fumarate 40 mg iron/day and ferrous sulphate 50 mg iron/day. Ferrous bisglycinate may be preferred for iron prophylaxis, especially in women experiencing GI side effects when taking other conventional iron formulas.
Journal Article
The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear—a double-blinded placebo controlled randomized trial
by
Perslev, Kathrine
,
Klarskov, Niels
,
Bergholt, Thomas
in
Acids
,
Amoxicillin
,
Anti-Bacterial Agents
2024
Background
Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administrated during delivery reduces this risk. We do not know if oral antibiotics given after delivery can reduce the risk of wound dehiscence or infection. Our aim is to investigate whether three doses of oral antibiotics (amoxicillin 500 mg/clavulanic acid 125 mg) given after delivery can reduce the risk of wound dehiscence and infection in patients with a second-degree obstetric tear or episiotomy.
Methods
We will perform a randomized, controlled, double-blinded study including 221women in each arm with allocation 1:1 in relation to the randomization. The study is carried out at Department of Obstetrics & Gynecology, Herlev University Hospital, Copenhagen, Denmark. The women will be included after delivery if they have had a second-degree tear or episiotomy. After inclusion, the women will have a clinical follow-up visit after 1 week. The tear and healing will be evaluated regarding signs of infection and/or dehiscence. The women will again be invited for a 1-year clinical examination including ultrasound. Questionnaires exploring symptoms related to the obstetric tear and possible complications will be answered at both visits. Our primary outcome is wound dehiscence and/or wound infection, which will be calculated using
χ
2
tests to compare groups. Secondary outcomes are variables that relate to wound healing, as pain, use of painkillers and antibiotics, need for further follow-up, as well as outcomes that may be related to the birth or healing process, urinary or anal incontinence, symptoms of prolapse, female body image, and sexual problems.
Discussion
Reducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment, and possibly also decrease both short-term and long-term symptoms. This would be of great importance so the mother, her partner, and the baby could establish and optimize their initial family relation.
Trial registration
The conduction of this study is approved the 2/2–2023 with the EU-CT number: 2022–501930-49–00. ClinicalTrials.gov Identifier: NCT05830162.
Journal Article
Women’s experiences of wound dehiscence of a second-degree perineal tear and choice of treatment in Denmark: a qualitative interview study
by
Hegaard, Hanne Kristine
,
Moestrup, Lærke Vinberg
,
Høgh, Stinne
in
Adult
,
Body mass index
,
Childbirth & labor
2026
ObjectiveThis study aimed to describe women’s experiences of perineal wound dehiscence of a second-degree perineal tear and choice of resuturing or conservative treatment in the first two months after birth.DesignA qualitative descriptive study using individual semistructured interviews was conducted. Data were analysed using Braun and Clarke’s reflexive thematic analysis approach to explore women’s experiences and perspectives on dehisced perineal wounds of a second-degree perineal tear. Interviews were audio-recorded, transcribed verbatim and analysed concurrently with data collection.SettingPerineal clinics at the Department of Obstetrics and Gynaecology at two large University Hospitals in Copenhagen, Denmark.Participants17 women with dehisced perineal wound of a second-degree perineal tear.ResultsThree main themes were identified: (1) The unforeseen troubles: for the women with perineal wound dehiscence, the pain intensified immensely after the birth. It was an unexpected complication, and it affected the women negatively in various ways. (2) The emotional turmoil: it was a crisis for the women that their lower bodies were not intact. They were terrified, and they wondered if they had themselves to blame. Most women emphasised that choosing between resuturing or conservative treatment was a difficult and lonely decision. (3) Living with changes: regardless of treatment approach, women in both groups reported gradually managing their complicated healing and pain, but were concerned about their genitals and future births.ConclusionsThe findings indicate that wound dehiscence was related to a painful postpartum period and an altered body image, and that the women generally found choosing between resuturing or conservative treatment difficult.
Journal Article
Broad-Spectrum Antibiotic Treatment and Subsequent Childhood Type 1 Diabetes: A Nationwide Danish Cohort Study
by
Bouaziz, Olivier
,
Bergholt, Thomas
,
Løkkegaard, Ellen C.
in
Adolescent
,
Analysis
,
Anti-Bacterial Agents - adverse effects
2016
Studies link antibiotic treatment and delivery by cesarean section with increased risk of chronic diseases through changes of the gut-microbiota. We aimed to evaluate the association of broad-spectrum antibiotic treatment during the first two years of life with subsequent onset of childhood type 1 diabetes and the potential effect-modification by mode of delivery.
A Danish nationwide cohort study including all singletons born during 1997-2010. End of follow-up by December 2012. Four national registers provided information on antibiotic redemptions, outcome and confounders. Redemptions of antibiotic prescriptions during the first two years of life was classified into narrow-spectrum or broad-spectrum antibiotics. Children were followed from age two to fourteen, both inclusive. The risk of type 1 diabetes with onset before the age of 15 years was assessed by Cox regression. A total of 858,201 singletons contributed 5,906,069 person-years, during which 1,503 children developed type 1 diabetes.
Redemption of broad-spectrum antibiotics during the first two years of life was associated with an increased rate of type 1 diabetes during the following 13 years of life (HR 1.13; 95% CI 1.02 to 1.25), however, the rate was modified by mode of delivery. Broad-spectrum antibiotics were associated with an increased rate of type 1 diabetes in children delivered by either intrapartum cesarean section (HR 1.70; 95% CI 1.15 to 2.51) or prelabor cesarean section (HR 1.63; 95% CI 1.11 to 2.39), but not in vaginally delivered children. Number needed to harm was 433 and 562, respectively. The association with broad-spectrum antibiotics was not modified by parity, genetic predisposition or maternal redemption of antibiotics during pregnancy or lactation.
Redemption of broad-spectrum antibiotics during infancy is associated with an increased risk of childhood type 1 diabetes in children delivered by cesarean section.
Journal Article
Risk Factors for Venous Thromboembolism in 1.3 Million Pregnancies: A Nationwide Prospective Cohort
2014
To quantify risk factors for venous thromboembolism during pregnancy and the puerperal period.
In a nationwide prospective cohort study we followed pregnant and puerperal women in Denmark from 1995 to 2009 for venous thromboembolism. Information on risk factors and confounders was retrieved from national registries. The diagnosis of venous thromboembolism was confirmed through medical charts. We calculated adjusted incidence rates per 10,000 women years and used Poisson regression to estimate effects during pregnancy and the puerperal period.
We studied 1,297,037 pregnancies and related puerperal periods, during which there were 748 venous thromboembolisms. The incidence rate for venous thromboembolism during a pregnancy with and without hospitalization for hyperemesis was 15.2/10,000 yr and 6.3/10,000 yr, respectively, (adjusted rate ratio: 2.5 (95%-confidence interval; 1.4-4.5)). The incidence rate among women with multiple pregnancies was 18.2/10,000 yr and 6.3/10,000 yr in singletons (adjusted rate ratio: 2.8 (1.9-4.2)). Increased risk was found with hospitalization during pregnancy or the puerperal period with incidence rates of 42.1/10.000 and 54.7/10.000, respectively, (rate ratios: 12.2 (8.7-17) and 5.9 (4.0-8.8)). Women hospitalized with infections during pregnancy had incidence rates of 25.9/10,000 yr and 29.3/10,000 yr during pregnancy and the puerperal period, respectively, and of 62.7/10,000 yr if hospitalized with infection in the puerperal period. Puerperal venous thromboembolism was associated with hospitalization for preeclampsia and intrauterine growth restriction/fetal death with incidence rates of 45.8/10,000 yr and 18.3/10,000 yr, respectively (rate ratio: 5.0 (3.1-7.8) and 1.9 (0.9-4.4)). Additionally puerperal venous thromboembolism was associated with obesity, elective and acute caesarean sections and major postpartum bleeding with incidence rates of 25.5/10,000 yr, 23.2/10,000 yr, 34.0/10,000 yr and 20.3/10,000 yr, respectively (rate ratios 1.7 (1.1-2.7), 2.1 (1.4-3.1), 3.0 (2.3-4.0) and 1.4 (1.0-2.1)).
Important risk factors for venous thromboembolism during pregnancy or the puerperal period were hospitalization, infection, hyperemesis, multiple pregnancies, preeclampsia, obesity, caesarean section, major postpartum bleeding, and intrauterine growth restriction or fetal death.
Journal Article
Maternal obesity and its effect on labour duration in nulliparous women: a retrospective observational cohort study
by
Bergholt, Thomas
,
Ellekjaer, Karen Louise
,
Løkkegaard, Ellen
in
Adult
,
Body Mass Index
,
Cesarean section
2017
Background
Obesity is increasing among primipara women. We aimed to describe the association between body mass index (BMI) during early-pregnancy and duration of labour in nulliparous women.
Methods
Retrospective observational cohort study of 1885 nulliparous women with a single cephalic presentation from 37 0/7 to 42 6/7 weeks of completed gestation and spontaneous or induced labour at Nordsjællands Hospital, University of Copenhagen, Denmark, in 2011 and 2012.
Total duration of labour and the first and second stages of labour were compared between early-pregnancy normal-weight (BMI <25 kg/m
2
), overweight (BMI 25–29.9 kg/m
2
), and obese (BMI ≥30 kg/m
2
) women. Proportional hazards and multiple logistic regression models were applied.
Results
Early pregnancy BMI classified 1246 (66.1%) women as normal weight, 350 (18.6%) as overweight and 203 (10.8%) as obese. No difference in the duration of total or first stage of active labour was found for overweight (adjusted HR = 1.01, 95% CI 0.88–1.16) or obese (adjusted HR = 1.07, 95% CI 0.90–1.28) compared to normal weight women. Median active labour duration was 5.83 h for normal weight, 6.08 h for overweight and 5.90 h for obese women.
The risk of caesarean delivery increased significantly for overweight and obese compared to normal weight women (odds ratios (OR) 1.62; 95%CI 1.18–2.22 and 1.76; 95%CI 1.20–2.58, respectively). Caesarean deliveries were performed earlier in labour in obese than normal-weight women (HR = 1.80, 95%CI 1.28–2.54).
Conclusion
BMI had no significant effect on total duration of active labour. Risk of caesarean delivery increased with increasing BMI. Caesarean deliveries are undertaken earlier in obese women compared to normal weight women following the onset of active labour, shortening the total duration of active labour.
Journal Article
Hunting for the elusive target antigen in gestational alloimmune liver disease (GALD)
by
Schlotmann, Balthasar Clemens
,
Holze, Henrietta
,
Jørgensen, Marianne Hørby
in
Analysis
,
Antibodies
,
Antigens
2023
The prevailing concept is that gestational alloimmune liver disease (GALD) is caused by maternal antibodies targeting a currently unknown antigen on the liver of the fetus. This leads to deposition of complement on the fetal hepatocytes and death of the fetal hepatocytes and extensive liver injury. In many cases, the newborn dies. In subsequent pregnancies early treatment of the woman with intravenous immunoglobulin can be instituted, and the prognosis for the fetus will be excellent. Without treatment the prognosis can be severe. Crucial improvements of diagnosis require identification of the target antigen. For this identification, this work was based on two hypotheses: 1. The GALD antigen is exclusively expressed in the fetal liver during normal fetal life in all pregnancies; 2. The GALD antigen is an alloantigen expressed in the fetal liver with the woman being homozygous for the minor allele and the father being, most frequently, homozygous for the major allele. We used three different experimental approaches to identify the liver target antigen of maternal antibodies from women who had given birth to a baby with the clinical GALD diagnosis: 1. Immunoprecipitation of antigens from either a human liver cell line or human fetal livers by immunoprecipitation with maternal antibodies followed by mass spectrometry analysis of captured antigens; 2. Construction of a cDNA expression library from human fetal liver mRNA and screening about 1.3 million recombinants in Escherichia coli using antibodies from mothers of babies diagnosed with GALD; 3. Exome/genome sequencing of DNA from 26 presumably unrelated women who had previously given birth to a child with GALD with husband controls and supplementary HLA typing. In conclusion, using the three experimental approaches we did not identify the GALD target antigen and the exome/genome sequencing results did not support the hypothesis that the GALD antigen is an alloantigen, but the results do not yield basis for excluding that the antigen is exclusively expressed during fetal life., which is the hypothesis we favor.
Journal Article
Effect of intensive nutrition training, education and support versus standard therapy in reducing the need for insulin therapy in gestational diabetes (INTENSE-GDM): a protocol for a randomised controlled single-centre trial in Denmark
2025
IntroductionGestational diabetes mellitus (GDM) poses health risks due to hyperglycaemia, which can lead to clinical complications for mother and child. While dietary therapy serves as first-line treatment, approximately one-third of women with GDM require insulin to obtain glycaemic control. However, insulin therapy amplifies hospital care expenses and personal burdens. Intensive nutrition education, training and support may improve dietary intake leading to glycaemic control and reducing the need for insulin therapy. This study investigates the effectiveness of intensified dietary therapy versus standard dietary therapy in reducing the need for insulin and consequently lowering hospital care costs among women with GDM at high risk of requiring insulin therapy. Responses to the dietary interventions will also be examined within ethnic subgroups.Methods and analysisThis study is a randomised controlled parallel-group trial involving women with GDM randomised in a 1:1 ratio to receive either intensive dietary therapy (intensive group) or standard dietary therapy with only one educational consultation (control group). The educational content of the first consultation is according to routine care and similar in both groups. The intensive group receives two additional dietitian consultations and two additional consultations on request to facilitate training and support in addition to education. Assessments are conducted at baseline and 2–3 weeks before planned delivery, with additional data gathered from medical records. The primary outcome is the difference in the proportion of women requiring insulin therapy. Maternal outcomes, neonatal outcomes, patient-reported outcomes, health behaviour and cost-saving aspects of hospital care will also be assessed. Recruitment began in January 2024 and ends in December 2025, with a target enrolment of 214 women.Ethics and disseminationThe study received approval from the Ethics Committee of the Capital Region of Denmark (H-23055674). Results will be disseminated through peer-reviewed journals, and detailed presentations to key stakeholders.Trial registration number NCT06127823.
Journal Article
Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial — the PRE-STORK trial
by
Danielsen, Julie Hagstrøm
,
Ghauri, Nida
,
Groth Grunnet, Louise
in
Adolescent
,
Adult
,
Body Mass Index
2025
IntroductionThe global prevalence of people living with overweight has tripled since 1975 and more than 40% of Danish women enter pregnancy being overweight. With the increasing rates of obesity observed in children, adolescents and adults, there is an urgent need for preventive measures. Risk factors for childhood obesity include maternal overweight or obesity before conception and excessive weight gain during pregnancy. Interventions aimed at modifying maternal lifestyle during pregnancy have demonstrated minimal positive or no impact on the health of the children. The ‘healthy lifestyle before and during pregnancy to prevent childhood obesity — the PRE-STORK trial’ aims to provide insights into the effect of a lifestyle intervention initiated before conception and continued during pregnancy in women with overweight or obesity, on neonatal adiposity in their children.Methods and analysisIn this randomised, two-arm, parallel-group, controlled trial, we will include 360 women with overweight or obesity (aged 18–40; body mass index 25–44 kg/m2) and their partners. The women will be randomised to receive either standard of care or a lifestyle intervention focused on preconception body weight reduction, regular physical exercise, healthy diet and support from a mentor before and during pregnancy. The primary outcome is the difference in neonatal adiposity measured in their children at birth. Children conceived during the trial will constitute a birth cohort, monitoring the effects on their health until the age of 18 years.Ethics and disseminationThe trial has been approved by the Regional Committee on Health Research Ethics in the Capital Region of Denmark (identification number H-22011403) and will be conducted in agreement with the Declaration of Helsinki. All results, whether positive, negative and inconclusive, will be disseminated at national or international scientific meetings and in peer-reviewed scientific journals.Trial registration numberClinicalTrials.gov: NCT05578690 (October 2022).
Journal Article