EAL

CD: Pregnancy Outcomes (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To determine the prevalence of gynecological and obstetric problems in patients with celiac disease and the influence of strict gluten restriction on their occurrence, the effect of pregnancy on the clinical course of celiac disease and the clinical features of those patients with onset of celiac disease during pregnancy and the puerperium.

Inclusion Criteria:

Diagnosis based on clinical, laboratory, and histological grounds.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Consecutive adult celiac women who attended the Small Bowel Section of the National Hospital of Gastroenterology over a period of 2 years, December 1991 - November 1993. Controls recruited from outpatient clinic.

Design

Case-control study.

Blinding used (if applicable)

Not used.

Intervention (if applicable)

Gynecological and obstetric history of celiac patients and healthy controls were compared.

Statistical Analysis

Statistical analysis was performed using the paired t-test, Mann-Whitney rank sum test and the Chi-square test, as appropriate.

Data Collection Summary:

Timing of Measurements

Each person interviewed by same interviewer about gynecological and obstetric history.

Dependent Variables

Age at menarche and menopause
Characteristics of menstrual cycle
Occurrence of amenorrhea lasting for more than 3 months
Number of pregnancies and spontaneous abortions
Status of maternal health during pregnancy and postpartum

Independent Variables

Gluten-free diet: degree of compliance assessed in interview. To assess influence of gluten-free diet on gynecological and obstetric history, subjects were divided into 2 groups. Group A (n=100) were those with newly diagnosed celiac disease who had not commenced a gluten-free diet, and those who had not adhered to gluten restriction. Group B (n=30) were those who had been diagnosed in infancy and adhered to strict gluten restriction.

Control Variables

Description of Actual Data Sample:

Initial N: 130 celiac patients, 130 healthy controls

Attrition (final N): See above

Age: Celiac patients median age 34 years (13 - 74 years), controls median age 32 years (14 - 77 years)

Ethnicity: Not mentioned

Other relevant demographics: Not mentioned

Anthropometrics: Controls were age- and sex-matched

Location: Argentina

Summary of Results:

	Untreated Celiac (n=100)	Controls	Treated Celiac (n=30)	Controls
Median Age	40.0	40.5	23.0	25.5
Median Age at Menarche	13.0	12.0	13.0	13.0
Delayed Age at Menarche	10	3	1	1
Median Age at Menopause	45.0	50.0	--	--
Secondary Amenorrhea	11	2	1	0
Pregnancies	240	246	25	22
Abortions	47	22	2	3

Other Findings

In comparison to the controls, untreated celiac disease patients exhibited significantly later menarche, an earlier menopause, an increased prevalence of secondary amenorrhea and a greater incidence of spontaneous abortions. No differences were observed in the number of pregnancies between groups.

Patients who had adhered, in the long term, to a gluten free diet had gynaecological and obstetric history indistinguishable from controls.

20% of pregnancies in untreated celiacs (9% in the respective control group, P < 0.03), but only 8% in treated patients (14% in controls, P = NS) ended in spontaneous abortions.

Clinical deterioration of celiac disease was observed in untreated patients during 17% of their pregnancies. In 14% of those untreated patients who were pregnant symptoms related to celiac disease were manifested for the first time during either pregnancy (n=7) or the puerperium (n=4).

9 of these patients had underestimated features suggestive of celiac disease.

Author Conclusion:

In conclusion, our study shows a high prevalence of gynecological and obstetric disturbances in association with untreated celiac disease. Celiac sprue must always be borne in mind when women develop diarrhea or weight loss during pregnancy and/or the puerperium. Finally, early diagnosis and treatment of celiac disease may prevent these complications.

Funding Source:

University/Hospital:

Salvador University (Buenos Aires, Argentina)

Reviewer Comments:

Dietary compliance assessed through interview but based on self-report. Inclusion/exclusion criteria not well defined. Only 30 of 130 subjects were compliant with diet.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		???
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	???
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes