Trial Outcomes & Findings for Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome (NCT NCT02498522)

NCT ID: NCT02498522

Last Updated: 2016-05-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 166 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-05-19

Participant Flow

Participant milestones

Measure	Metformin Arm 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Control Arm 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
Overall Study STARTED	85	85
Overall Study COMPLETED	83	83
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome

Baseline characteristics by cohort

Measure	Metformin Arm n=83 Participants 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Control Arm n=83 Participants 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Total n=166 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	83 Participants n=5 Participants	83 Participants n=7 Participants	166 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.2 years STANDARD_DEVIATION 1.6 • n=5 Participants	30.1 years STANDARD_DEVIATION 1.9 • n=7 Participants	30.1 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	83 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	83 participants n=5 Participants	83 participants n=7 Participants	166 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Metformin Arm n=83 Participants 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Control Arm n=83 Participants 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
Miscarriage Rate	9 participants Interval 4.1 to 17.5	35 participants Interval 31.6 to 52.8

Adverse Events

Metformin Arm

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metformin Arm n=83 participants at risk 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Control Arm n=83 participants at risk 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
Gastrointestinal disorders vomiting	19.3% 16/83 • Number of events 16	7.2% 6/83 • Number of events 6

Additional Information

Dr. Ahmed kotb

AinShamsU

Phone: 1008681999

Email: ahmedmkotp@hotmail.com

Results disclosure agreements

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

Restriction type: LTE60