Trial Outcomes & Findings for Effects of a Personalized Web-based Antenatal Care Planner (NCT NCT00182325)

NCT ID: NCT00182325

Last Updated: 2019-06-10

Results Overview

Number of log-ins

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

193 participants

Primary outcome timeframe

11 months

Results posted on

2019-06-10

Participant Flow

Participant milestones

Participant milestones
Measure
Personalized Information and Internet Access
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Overall Study
STARTED
97
96
Overall Study
COMPLETED
63
43
Overall Study
NOT COMPLETED
34
53

Reasons for withdrawal

Reasons for withdrawal
Measure
Personalized Information and Internet Access
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Overall Study
Lost to Follow-up
7
7
Overall Study
Miscarriage
5
3
Overall Study
Did not complete survey
22
43

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Personalized Information and Internet Access
n=97 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=96 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Total
n=193 Participants
Total of all reporting groups
Age, Continuous
27.7 years
STANDARD_DEVIATION 5.3 • n=97 Participants
26.4 years
STANDARD_DEVIATION 5.6 • n=96 Participants
27.1 years
STANDARD_DEVIATION 5.5 • n=193 Participants
Sex: Female, Male
Female
97 Participants
n=97 Participants
96 Participants
n=96 Participants
193 Participants
n=193 Participants
Sex: Female, Male
Male
0 Participants
n=97 Participants
0 Participants
n=96 Participants
0 Participants
n=193 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Married or common-law
75 Participants
n=95 Participants • Full demographic information was available only for the women who completed the surveys.
72 Participants
n=92 Participants • Full demographic information was available only for the women who completed the surveys.
147 Participants
n=187 Participants • Full demographic information was available only for the women who completed the surveys.
Primiparous
60 Participants
n=93 Participants • Full demographic information was available only for the women who completed the surveys.
64 Participants
n=93 Participants • Full demographic information was available only for the women who completed the surveys.
124 Participants
n=186 Participants • Full demographic information was available only for the women who completed the surveys.
At least some post-secondary education
58 Participants
n=91 Participants • Full demographic information was available only for the women who completed the surveys.
59 Participants
n=90 Participants • Full demographic information was available only for the women who completed the surveys.
117 Participants
n=181 Participants • Full demographic information was available only for the women who completed the surveys.

PRIMARY outcome

Timeframe: 11 months

Population: An intention-to-treat analysis was conducted. Participants were included in the analysis that started or completed the survey and excludes participants that were lost to follow-up or had a miscarriage.Intervention group: 63 completed survey + 22 partially complete survey =85). Control group: 53 completed survey + 43 partially complete survey = 96).

Number of log-ins

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=85 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=89 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Uptake of Service
10.4 Log-ins
Standard Deviation 17.8
1.8 Log-ins
Standard Deviation 1.4

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Easy to Log on
1.4 score on a scale
Standard Deviation 0.5
1.5 score on a scale
Standard Deviation 0.9

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Information Easy to Understand
1.4 score on a scale
Standard Deviation 0.5
1.5 score on a scale
Standard Deviation 0.6

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Learned Something New
1.8 score on a scale
Standard Deviation 0.9
1.9 score on a scale
Standard Deviation 0.8

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Easy to Find Information
1.9 score on a scale
Standard Deviation 0.9
1.8 score on a scale
Standard Deviation 0.7

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Helped me Stay Healthy
1.8 score on a scale
Standard Deviation 0.8
1.6 score on a scale
Standard Deviation 0.7

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Helped me Learn About Risks
1.9 score on a scale
Standard Deviation 0.8
1.8 score on a scale
Standard Deviation 0.8

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Helped me Understand Tests
1.7 score on a scale
Standard Deviation 0.7
1.6 score on a scale
Standard Deviation 0.8

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Helped me Make Decisions
2.1 score on a scale
Standard Deviation 0.9
2.4 score on a scale
Standard Deviation 1.2

PRIMARY outcome

Timeframe: 11 months

Population: The number of completed surveys was 63 (64.9%) in the personalized information and Internet access group, and 43 (44.8%) in the general resource Internet access group.

Women were asked to rate their agreement with statements about the website from strongly agree (1) to strongly disagree (5) on a five-point scale. Results presented here are mean responses to questionnaire about the pregnancy website in the two randomized groups.

Outcome measures

Outcome measures
Measure
Personalized Information and Internet Access
n=63 Participants
Women in this group were given access to their own personal antenatal health record and personalized information through the clinic's antenatal care planner, as well as access to the study site website, which provided links to pregnancy information that was pre-approved by the study team.
General Resource Internet Access
n=43 Participants
Women in this group were given access to the study site website, which provided links to pregnancy information that was pre-approved by the study team
Helped me Remember Appointments
2.9 score on a scale
Standard Deviation 1.3
3.5 score on a scale
Standard Deviation 1.4

Adverse Events

Personalized Information and Internet Access

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

General Resource Internet Access

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Waters

Department of Family Medicine, McMaster University

Phone: (905) 575-6782

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place