Methods

RCT.

Participants

55 women with raised blood pressure and, or pre‐eclampsia, who "would normally have been admitted to hospital for monitoring blood pressure... provided that her condition was not so severe that admission was mandatory".

Setting: London hospital, UK, 1984.

Interventions

Intervention group: admission to the day care unit (a side ward of the obstetric unit) with 2‐hourly blood pressure monitoring.

Comparison group: hospital admission.

Outcomes

Maternal and perinatal morbidity and mortality, Apgar score, subsequent management.

Notes

Published and unpublished data were used for data extraction.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

"Allocated at random."

Allocation concealment?

Unclear risk

No information provided.

Blinding?
Women

High risk

Different care management.

Blinding?
Clinical staff

High risk

Blinding?
Outcome assessors

High risk

Incomplete outcome data addressed?
All outcomes

Unclear risk

55 women were randomised. It was not clear in the results whether all women were accounted for (in the unpublished paper 1 woman with serious morbidity who was not followed up in the study hospital was re‐included in our analyses).

Free of selective reporting?

Unclear risk

Data were derived from a short abstract and unpublished data, little information was provided.

Free of other bias?

Unclear risk

The mean diastolic blood pressure at baseline was higher in the day unit group: 98 versus 94 mm Hg in the comparison group.

Methods

RCT.

Women were informed of group allocation at recruitment (Zelen's pre‐consent randomisation).

Participants

54 out of 59 eligible women were enrolled in the study and randomised. 30 women were enrolled in the day care group, 24 in the control group.

Inclusion criteria: women presenting at 26 weeks of pregnancy or later with non‐proteinuric hypertension (diastolic BP > 90 mm Hg and/or systolic BP >150 mm Hg for 2 readings at least 15 minutes apart).

Exclusion criteria: women that had had a previous admission to hospital during the index pregnancy and women with proteinuria or with a diastolic BP > 105 mm Hg or systolic BP > 170 mm Hg.

Setting: hospital in Leeds, UK in 1989.

All women randomised completed the trial.

Interventions

Intervention group: patients referred to the day unit were seen the morning after referral. 5 BP readings were made; urine was checked for protein; platelet count and serum urate concentration were measured; and a cardiotocograph was done. Doppler waveform analyses were done if considered necessary by the clinician. After each visit the woman was reviewed, and further visits were arranged according to perceived clinical need; either discharged back to clinic, followed up in the day unit, or admitted to hospital.
Comparison group: patients in the control group were managed according to the judgement and established practice of the referring clinician. This did not necessarily entail admission to the hospital. In the experimental group, 16 women were admitted to hospital without further review, 5 were reviewed by the community midwife 48‐96 hours later and 3 were given appointments to the next antenatal clinic. 3 patients allocated to the control group were referred to the day unit.

Outcomes

A record was kept of the woman's blood pressure, weight and stage of gestation at referral, and the action taken after randomisation. Outpatient attendance and admissions and the proportion of time in hospital were recorded prospectively from day of entry to the study to delivery. Clinical complications, the method of management, and labour and delivery details were recorded. Patient satisfaction was assessed by a confidential postal questionnaire sent to all women 4 to 6 weeks after delivery.

Notes

Economic analyses were performed but not published. Sample size of 25 women in each arm of the study would have an 80% chance of detecting a 50% reduction in duration of stay at P < 0.05 with a 1‐tailed test. 5 eligible women did not enter the study, and were not randomised, because the referring doctors preferred to use the day care unit.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

Decribed as "simple randomisation".

Allocation concealment?

Low risk

Sealed opaque sequentially numbered envelopes opened by midwife who had had no previous contact with the women.

Blinding?
Women

High risk

Care options were discussed with the women (Zelen randomisation ‐ randomisation before consent, no women withdrew after randomisation).

Blinding?
Clinical staff

High risk

Different care protocols.

Blinding?
Outcome assessors

High risk

Case notes would have revealed group allocation.

Incomplete outcome data addressed?
All outcomes

Unclear risk

Full data available for outcomes collected during the antenatal period and for delivery.

9 women, 3 in the control group and 6 in the intervention group, did not return postal questionnaires about patient satisfaction (17% attrition) which was completed 4‐6 weeks after delivery.

Free of selective reporting?

Low risk

None apparent. Non‐significant findings reported.

Free of other bias?

Unclear risk

The mean systolic BP was slightly higher in the comparison group (day care group mean 140 (SD 8) comparison group mean 134 (SD 9).

Methods

Parallel RCT; Zelen design with double consent.

Participants

395 women being admitted to the day care unit as an alternative to hospital admission.

Inclusion criteria: women with 3 clinical disorders (proteinuric hypertension, non‐proteinuric hypertension or PPROM after 28 weeks) for which there was no clear clinical indication for inpatient admission or any indication of fetal compromise. A woman with PPROM at 28 weeks' gestation or later was considered for inclusion if initial assessment indicated that labour was not imminent, there were no signs of infection or haemorrhage, she lived within 40 minutes of the hospital and she had been an inpatient for less than a week. (Indications for immediate admission: systolic blood pressure > 160 mmHg, diastolic blood pressure > 110 mmHg, proteinuria of +++ or more on dipstick testing; any clinical indication of irritability of the central nervous system or splanchnic congestion; any biochemical signs of organ dysfunction (such as abnormal liver or renal function test results or evidence of haemolysis or thrombocytopenia)).

Exclusion criteria: women presenting for cardiotocography alone were excluded; also multiple pregnancy, inability to communicate in English, and previous admission in the current pregnancy for the presenting complication.

Setting: tertiary women's hospital, Adelaide, Australia.

Interventions

Intervention group: day care unit. Unit with sitting and dining areas and a "deinstitutionalised environment". Families were able to accompany women. The unit was open between 09.00 to 17.00 hrs. Tests were initiated on admission with review after 2‐3hours.

Comparison group: admission to medical ward with limited visiting hours and a stay of at least 1 night.

Outcomes

Clinical outcomes, maternal satisfaction with care and psychological wellbeing (questionnaires 4 days after randomisation and 7 weeks post delivery). Economic data.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

External randomisation by computer‐generated sequence.

Allocation concealment?

Low risk

Third party telephone randomisation (Zelen method, patients randomised before final consent).

Blinding?
Women

High risk

Women aware of treatment alternatives.

Blinding?
Clinical staff

High risk

Different care packages.

Blinding?
Outcome assessors

High risk

Some data extraction from notes was carried out by midwives not providing care but the notes are likely to have included details of management.

Incomplete outcome data addressed?
All outcomes

Low risk

26 women (7%) did not receive care according to the allocation but they were analysed by randomisation group. Low rates of attrition for outcomes collected from notes (< 5%). The response rate for women's questionnaires 4 days post randomisation was relatively high (approximately 88%).

Free of selective reporting?

Low risk

None apparent, but pre‐specified outcomes were very broad (e.g. that day care units would result in "no difference in clinical outcome").

Free of other bias?

Low risk

Both groups had similar baseline characteristics, although there were slightly more smokers in the comparison group (14.4%) compared with the day care group (12.5%).