Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial.

BACKGROUND: Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness (RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility. METHODS: Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound. TRIAL REGISTRATION: Dutch Trial Register ( NTR5480 ). Registered 29 October 2015.

Individualized choice in prenatal diagnosis: the impact of karyotyping and standalone rapid aneuploidy detection on quality of life.

OBJECTIVE: To assess the reasons and perceptions of women who are offered a choice between karyotyping and standalone rapid aneuploidy detection (RAD) and to compare the impact of both tests on anxiety and health-related quality of life. METHODS: In this prospective comparative study, women undergoing amniocentesis on behalf of their age or for an increased Down syndrome risk were offered a choice between karyotyping (group 1, n = 68) and standalone RAD (group 2, n = 61). Follow-up was 9 weeks post amniocentesis. RESULTS: The most commonly cited reason for choosing karyotyping was obtaining as much information as possible, while for choosing standalone RAD, it was the short waiting time. Prenatal screening (OR 7.09), no knowledge of karyotyping (OR 4.2), and an intermediate perceived risk for chromosomal abnormalities (OR 3.6) were associated with choosing standalone RAD. There were no systematic differences in time of karyotyping and standalone RAD in terms of anxiety (P = 0.11), generic physical and mental health (P = 0.94, 0.52; P = 0.66, 0.07), personal perceived control (PPC; P = 0.69), and stress (P = 0.66). CONCLUSION: Offering a choice between karyotyping and standalone RAD does not influence anxiety, stress, PPC, or generic health. Individual choice in prenatal diagnosis meets individual needs and thereby could reduce anxiety and stress.

The impact of rapid aneuploidy detection (RAD) in addition to karyotyping versus karyotyping on maternal quality of life.

OBJECTIVE: To assess the impact of rapid aneuploidy detection (RAD) combined with fetal karyotyping versus karyotyping only on maternal anxiety and health-related quality of life. METHODS: Women choosing to undergo amniocentesis were selected into group 1, i.e. receiving a karyotype result only (n = 132) or to group 2, i.e. receiving both the result of RAD and karyotyping (n = 181). RESULTS: There were no systematic differences in time of RAD combined with karyotyping versus karyotyping only in terms of anxiety (P = 0.91), generic physical health (P = 0.76, P = 0.46), generic mental health (P = 0.52, P = 0.72), personal perceived control (P = 0.91) and stress (P = 0.13). RAD combined with karyotyping reduced anxiety and stress two weeks earlier compared to karyotyping only. CONCLUSION: RAD as add-on to karyotyping reduces anxiety and stress in the short term but it does not influence overall anxiety, stress, personal perceived control, and generic mental and physical health when compared to a karyotype-only strategy.

Karyotyping or rapid aneuploidy detection in prenatal diagnosis? The different views of users and providers of prenatal care.

Developments in prenatal diagnosis raise the question which test strategy should be implemented. However, preferences of women and caregivers are underexposed. This study investigates what kind of prenatal test pregnant women and caregivers prefer and if differences between the groups exist, using self-report questionnaires. Women preferred either karyotyping (50%) or rapid aneuploidy detection (43%). Caregivers opted for the latter (78%). A test targeted on Down syndrome was the least preferred in both groups. We recommend the use of individualised choice for genetic test in prenatal diagnosis, overcoming the existing differences in preferences between women and caregivers.

[Spontaneous liver haemorrhage during pregnancy: a rare and life-threatening situation]. / Een spontane leverbloeding tijdens de zwangerschap: een zeldzame, levensbedreigende situatie.

Three pregnant women, of whom 2 were 33 and 1 was 35 years of age, were seen; 2 of them had upper abdominal pain and 1had oedema. All had proteinuria and liver enzyme abnormalities, and pre-eclampsia or the HELLP syndrome was suspected. They were consequently admitted and at first treated with antihypertensive agents. One patient underwent a Caesarean section and the baby had a good start. Afterwards, however, the patient developed shock. A CT-scan revealed a hepatic rupture, for which repeated surgical packing of the liver was carried out. The postoperative course was complicated. A second patient developed shock and the foetus died. Here the CT-scan revealed a liver haematoma. At surgery the next day, removal of the foetus was followed by heavy uterine bleeding. The patient again developed shock and the uterus was resected. A haematoma that was seen in the liver was treated expectatively. The postoperative course was not complicated. In a third patient, abdominal echography revealed bleeding from the liver. Simultaneous Caesarean section and surgical exploration of the liver took place, with packing of the liver. The child had Apgar scores of 4, 7 and 9. After re-laparotomy because of persistent bleeding from the liver the patient recovered. Spontaneous liver haemorrhage and hepatic rupture during pregnancy is a rare condition associated with significant maternal and perinatal mortality. The majority of cases occur during pregnancies complicated by pre-eclampsia or the HELLP syndrome. The presenting symptoms are non-specific. A high index of suspicion is important and early evaluation with imaging is necessary to improve the prognosis of both mother and child.