The psychological effects and patient acceptability of a test to predict viability in early pregnancy: a prospective randomised study

Davison, A. Z.; Sana, Y.; Johns, Jemma; Ross, Jackie

doi:10.1016/j.ejogrb.2014.04.002

Cited by 15 publications

(12 citation statements)

References 9 publications

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“…Our findings differ from those of a similar smaller study of 139 women, which found that offering a probability of viability was psychologically beneficial to women when assessed 7 days after an initial ultrasound scan 7 . It is possible that women in that study may have placed more value on the prediction score, due to the addition of a physical blood sample for progesterone measurement.…”

Section: Discussioncontrasting

confidence: 99%

“…This finding may represent a normally developing (but early) pregnancy. However, up to 50% of these pregnancies will eventually miscarry [4][5][6][7][9][10][11][12] Richardson et al demonstrated that anxiety in early pregnancy is highest in women with an intrauterine pregnancy of uncertain viability compared to women who are informed of an ongoing pregnancy, ectopic gestation or miscarriage (a certain diagnosis) at the initial ultrasound 8 .…”

Section: Introductionmentioning

confidence: 99%

“…In the UK, 10-28% of women seen in early pregnancy units are found to have an intrauterine pregnancy of uncertain viability at initial assessment [4][5][6][7][8] . Solely an ultrasound outcome, these women have a correctly sited pregnancy within the uterus, but the viability of the pregnancy (heartbeat visualization) is not confirmed.…”

Section: Introductionmentioning

confidence: 99%

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Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial

Lawson

Bourne

Bottomley

2023

Ultrasound in Obstet & Gyne

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ObjectiveTo investigate whether psychological wellbeing of women with an intrauterine pregnancy of uncertain viability can be modified during the waiting period to final diagnosis, by offering predictive information regarding the likely outcome of the pregnancy (chance of ongoing viability).MethodsThis was a single‐center two‐arm randomized controlled trial conducted over 18 months at a teaching hospital in London, UK. Consecutive eligible women attending the early pregnancy assessment unit with an interim ultrasound finding of intrauterine pregnancy of uncertain viability were recruited. All women were offered a follow‐up ultrasound scan after 14 days. Participants were randomized to receive a prediction score for ongoing viability at 14 days or routine care (control). Anxiety, depression and worry symptoms were assessed using validated self‐report questionnaires (hospital anxiety and depression scale (HADS), Penn state worry questionnaire (PSWQ)) prior to randomization and at two further timepoints during the waiting period preceding final diagnosis. The change in psychological scores over the study period was analyzed. The secondary outcome was the perceived value of the risk prediction tool reported by participants.ResultsA total of 278 women participated in this study. After adjusting for baseline scores, no difference in anxiety, depression or worry scores was demonstrated between control and intervention groups at either timepoint. Subgroup analysis, first of women with high initial anxiety (HADS > 11) or worry (PSWQ ≥ 45), and second of women with a more favorable predicted prognosis (≥ 75% chance of ongoing viability), demonstrated no difference between intervention and control groups. Despite this, 76/110 (69.1% (95% CI, 60.5–78.4%)) women who provided feedback in the intervention group found it to be helpful and 97/110 (88.2% (95% CI, 81.0–93.7%)) reported that they would use the tool again.ConclusionCurrent prediction tools may be useful for healthcare professionals to guide management and optimize utilization of early pregnancy resources. However, in this study, implementation of an accurate tool did not result in an objective measurable benefit to patients in terms of reduction in anxiety, depression and worry symptoms experienced during the waiting period to final outcome compared with women who did not receive a prediction score. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

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Section: Discussioncontrasting

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial

Lawson

Bourne

Bottomley

2023

Ultrasound in Obstet & Gyne

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“…Since no other investigations were performed, no additional information was available to alter anxiety levels. Even if further investigations are not definitive, there is evidence to suggest that women would benefit psychologically from tests that give them an indication of what a subsequent ultrasound examination might show.…”

Section: Discussionmentioning

confidence: 99%

Anxiety associated with diagnostic uncertainty in early pregnancy

Richardson

Raine‐Fenning

Deb

et al. 2017

Ultrasound in Obstet & Gyne

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Objectives: To determine anxiety levels of women presenting to Early Pregnancy Assessment Units (EPAU) with abdominal pain and/or vaginal bleeding and assess how these change over time and according to ultrasonographic diagnosis. Methods:We undertook a prospective cohort study in a EPAU in a large UK teaching hospital. Women with abdominal pain and/or vaginal bleeding in early pregnancy (less than 12 weeks gestation) presenting for the first time were eligible for inclusion in the study. State anxiety levels were assessed using the standardised short form of Results: 160 women were included in the study. Anxiety levels decreased over time for women with certain diagnoses (n=128), even when negative (n=64), and increased over time for women with uncertain diagnoses (n=32). Before the ultrasound, anxiety levels were high (21.96±1.11) and there was no significant difference between the five groups. Immediately after the ultrasound, anxiety levels were lower in the viable IUP group (n=64; 7.75±1.13) than any other group. The difference between the five groups was significant (p<0.005). 48-72 hours later, women with certain diagnoses had significantly lower anxiety levels than those with uncertain diagnoses (10.77±4.30 vs 22.94±1.65: p<0.005).3 Conclusions:The experience of abdominal pain and/or vaginal bleeding in early pregnancy is highly anxiogenic. Following an ultrasound, the certainty of the diagnosis affects anxiety levels more than the positive or negative connotations associated with the diagnosis per se. All healthcare providers should be aware of this when communicating uncertain diagnoses.

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“…The requirement to repeat scans will inevitably leave women in a state of uncertainty that may be distressing. Evidence shows that giving women information about the likely outcome can manage expectations and reduce anxiety,12 and scoring systems and models now exist that give an accurate prediction regarding the likelihood of miscarriage 13…”

Section: Discussionmentioning

confidence: 99%

Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

Preisler

Kopeika

Ismail

et al. 2015

BMJ

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ObjeCtivesTo validate recent guidance changes by establishing the performance of cut-off values for embryo crownrump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.) DesignProspective multicentre observational trial.setting Seven hospital based early pregnancy assessment units in the United Kingdom.PartiCiPants 2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm. Main OutCOMe MeasuresMean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks' gestation. resultsThe following indicated a miscarriage at initial scan: mean gestational sac diameter ≥25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ≥7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ≥18 mm for gestational sacs without an embryo presenting after 70 days' gestation (907/907 specificity: 100%, 99.6% to 100%), embryo with crown-rump length ≥3 mm without visible heart activity presenting after 70 days' gestation (87/87 specificity: 100%, 95.8% to 100%). The following were indicative of miscarriage at a repeat scan: initial scan and repeat scan after seven days or more showing an embryo without visible heart activity (103/103 specificity: 100%, 96.5% to 100%), pregnancies without an embryo and mean gestational sac diameter <12 mm where the mean diameter has not doubled after 14 days or more (478/478 specificity: 100%, 99.2% to 100%), pregnancies without an embryo and mean gestational sac diameter ≥12 mm showing no embryo heartbeat after seven days or more (150/150 specificity: 100%, 97.6% to 100%). COnClusiOnsRecently changed cut-off values of gestational sac and embryo size defining miscarriage are appropriate and not too conservative but do not take into account gestational age. Guidance on timing between scans and expected findings on repeat scans are still too liberal. Protocols for miscarriage diagnosis should be reviewed to account for this evidence to avo...

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The psychological effects and patient acceptability of a test to predict viability in early pregnancy: a prospective randomised study

Cited by 15 publications

References 9 publications

Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial

Psychological impact of simple scoring system for predicting early pregnancy outcome in pregnancy of uncertain viability: randomized controlled trial

Anxiety associated with diagnostic uncertainty in early pregnancy

Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

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