Labor Onset and Length Abnormalities, Obesity, Pregnancy Related
Conditions
Keywords
Induction of Labor, Cervical Ripening, Misoprostol, Obesity
Brief summary
The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.
Detailed description
As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several research studies in the past designed to look at the fastest and safest method for labor induction, however very few studies have been done in women with a Body Mass Index (BMI) greater than or equal to 30 kg/m2. Women with a BMI greater than or equal to 30 kg/m2, also classified as Obesity, are known to have longer labor induction times and experience more failed labor inductions requiring cesarean delivery (C-Sections). Obese women are also at a higher risk of developing complications during labor and postpartum such as excessive vaginal bleeding and infections. Due to limited information, the American College of Obstetricians and Gynecologists (ACOG) currently recommends a standard dosing of 25 or 50 micrograms of vaginal misoprostol for labor induction in all women. However, there are studies which specifically compared the 25 microgram and 50 microgram misoprostol doses and found that women have significantly shorter time to deliveries without any harmful effects to mother or baby. The investigators will conduct a randomized controlled trial to determine if 50 micrograms of vaginal misoprostol, when compared to the standard 25 micrograms, reduces the time from the start of labor induction to delivery in obese women. Women who are admitted to Labor & Delivery for the purposes of labor induction will be randomized to undergo either 25 micrograms or 50 micrograms of vaginal misoprostol for cervical ripening. Women and their infants will be followed until the time of their discharge.
Interventions
DRUG50 Micrograms Vaginal Misoprostol (Intervention)
Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.
DRUG25 Micrograms Vaginal Misoprostol (Control)
Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
This study will be double blinded with the research participants and providers/nursing masked to the interventions.
Intervention model description
Participants are assigned to one of two groups (intervention versus control) in parallel for the duration of the study. Randomization will occur according to a predetermined computer-generated stratified randomization scheme prepared by a study statistician.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Singleton gestation 2. Age 18 years or older 3. Gestational age \>= 36 weeks 4. BMI \>= 30 kg/m2 at time of labor induction 5. Cephalic presentation (including successful external cephalic version) 6. Cervical dilation \<= 3cm 7. Intent to proceed with cervical ripening
Exclusion criteria
1. Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.) 2. Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.) 3. Multiple gestations 4. Gestational age \< 36 weeks 5. Non-reassuring fetal heart tracing 6. Evidence of clinical chorioamnionitis 7. Significant vaginal bleeding with concern for abruption 8. Prior cesarean delivery or uterine surgery 9. Major fetal anomaly or demise 10. Cervix \>3cm 11. No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.) 12. Uterine tachysystole (defined as \>= 5 contractions within a 10m period) 13. Fetal Growth Restriction (EFW \<= 5% or elevated/absent/reversed Umbilical Artery dopplers) 14. Inability to give consent (inability to read/write in English or Spanish)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) | From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cesarean Deliveries | Assessed following delivery, through study completion which is estimated at 1 year. | — |
| Number of Participants Exhibiting Uterine Tachysystole | Assessed 4 hours post-misoprostol placement | Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period |
| Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations | Assessed 4 hours post-misoprostol placement | Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period. Decelerations are defined by the 2008 NICHD Fetal Monitoring Terminology. |
| Number of Participants Receiving Terbutaline | From baseline to the time of delivery | — |
| Number of Participants Diagnosed With Clinical Chorioamnionitis | From baseline to the time of delivery | — |
| Number of Participants Diagnosed With Postpartum Hemorrhage | Assessed at time of delivery | — |
| Patient Satisfaction Six Simple Questions, Question 1 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 1: Experience has shown that I can have appropriate and adequate control over my care. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
| Patient Satisfaction Six Simple Questions, Question 2 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 2: The person(s) responsible for my care are/were caring and compassionate. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
| Interval Time From Labor Induction to Vaginal Delivery | From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days | — |
| Patient Satisfaction Six Simple Questions, Question 4 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
| Patient Satisfaction Six Simple Questions, Question 5 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 5: The overall organization of my care has not been appropriate. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
| Patient Satisfaction Six Simple Questions, Question 6 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 6: I would choose the same type of care for my next pregnancy. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
| Patient Satisfaction (Labor Pain Scale, Question 1) | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0 |
| Patient Satisfaction (Labor Pain Scale, Question 2) | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain that you experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0 |
| Patient Satisfaction (Labor Pain Scale, Question 3) | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 3: Worst amount of pain you experienced following placement of the misoprostol Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0 |
| Patient Satisfaction (Labor Pain Scale, Question 4) | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member? Please rate from 0 (strongly recommend) to 10 (strongly DO NOT recommend). Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 0 Worst score: 10 |
| Patient Satisfaction Six Simple Questions, Question 3 | Assessed postpartum day one following delivery, up to 5 days post-delivery. | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
50 Micrograms Vaginal Misoprostol (Intervention): Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours. | 91 |
| 25 Micrograms Vaginal Misoprostol (Control) Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
25 Micrograms Vaginal Misoprostol (Control): Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours. | 88 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | 50 Micrograms Vaginal Misoprostol (Intervention) | 25 Micrograms Vaginal Misoprostol (Control) | Total |
|---|---|---|---|
| Age, Continuous | 28.63 years STANDARD_DEVIATION 7.48 | 27.49 years STANDARD_DEVIATION 6.73 | 28.07 years STANDARD_DEVIATION 7.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 66 Participants | 64 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 23 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Nulliparous | 55 Participants | 51 Participants | 106 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) White | 79 Participants | 77 Participants | 156 Participants |
| Sex: Female, Male Female | 91 Participants | 88 Participants | 179 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 88 |
| other Total, other adverse events | 18 / 91 | 23 / 88 |
| serious Total, serious adverse events | 2 / 91 | 5 / 88 |
Outcome results
Primary
Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)
Time frame: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) | 18.56 hours | Standard Deviation 9.92 |
| 25 Micrograms Vaginal Misoprostol (Control) | Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) | 21.59 hours | Standard Deviation 11.11 |
Secondary
Interval Time From Labor Induction to Vaginal Delivery
Time frame: From baseline (baseline is initiation of labor induction) to the time of vaginal delivery, up to 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Interval Time From Labor Induction to Vaginal Delivery | 17.20 hours | Standard Deviation 9.22 |
| 25 Micrograms Vaginal Misoprostol (Control) | Interval Time From Labor Induction to Vaginal Delivery | 19.00 hours | Standard Deviation 10.76 |
Secondary
Number of Cesarean Deliveries
Time frame: Assessed following delivery, through study completion which is estimated at 1 year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Cesarean Deliveries | 25 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Cesarean Deliveries | 24 Participants |
Secondary
Number of Participants Diagnosed With Clinical Chorioamnionitis
Time frame: From baseline to the time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Participants Diagnosed With Clinical Chorioamnionitis | 8 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Participants Diagnosed With Clinical Chorioamnionitis | 10 Participants |
Secondary
Number of Participants Diagnosed With Postpartum Hemorrhage
Time frame: Assessed at time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Participants Diagnosed With Postpartum Hemorrhage | 12 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Participants Diagnosed With Postpartum Hemorrhage | 17 Participants |
Secondary
Number of Participants Exhibiting Uterine Tachysystole
Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period
Time frame: Assessed 4 hours post-misoprostol placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Participants Exhibiting Uterine Tachysystole | 20 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Participants Exhibiting Uterine Tachysystole | 9 Participants |
Secondary
Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations
Tachysystole is defined as greater than or equal to 5 contractions within a 10 minute period. Decelerations are defined by the 2008 NICHD Fetal Monitoring Terminology.
Time frame: Assessed 4 hours post-misoprostol placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations | 2 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations | 2 Participants |
Secondary
Number of Participants Receiving Terbutaline
Time frame: From baseline to the time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Number of Participants Receiving Terbutaline | 2 Participants |
| 25 Micrograms Vaginal Misoprostol (Control) | Number of Participants Receiving Terbutaline | 1 Participants |
Secondary
Patient Satisfaction (Labor Pain Scale, Question 1)
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction (Labor Pain Scale, Question 1) | 8 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction (Labor Pain Scale, Question 1) | 8 score on a scale |
Secondary
Patient Satisfaction (Labor Pain Scale, Question 2)
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain that you experienced during labor. Scale 0-10. 0 = no pain, 10 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction (Labor Pain Scale, Question 2) | 6 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction (Labor Pain Scale, Question 2) | 6.5 score on a scale |
Secondary
Patient Satisfaction (Labor Pain Scale, Question 3)
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 3: Worst amount of pain you experienced following placement of the misoprostol Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 10 Worst score: 0
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction (Labor Pain Scale, Question 3) | 5 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction (Labor Pain Scale, Question 3) | 5 score on a scale |
Secondary
Patient Satisfaction (Labor Pain Scale, Question 4)
Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of misoprostol, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member? Please rate from 0 (strongly recommend) to 10 (strongly DO NOT recommend). Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 10 patient satisfaction. Ranges: 0-10 Best score: 0 Worst score: 10
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction (Labor Pain Scale, Question 4) | 2 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction (Labor Pain Scale, Question 4) | 2 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 1
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 1: Experience has shown that I can have appropriate and adequate control over my care. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 1 | 6 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 1 | 6 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 2
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 2: The person(s) responsible for my care are/were caring and compassionate. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 2 | 7 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 2 | 7 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 3
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 3 | 2 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 3 | 2 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 4
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 4 | 6 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 4 | 7 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 5
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 5: The overall organization of my care has not been appropriate. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 5 | 2 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 5 | 2 score on a scale |
Secondary
Patient Satisfaction Six Simple Questions, Question 6
Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 6: I would choose the same type of care for my next pregnancy. 1=strongly disagree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1
Time frame: Assessed postpartum day one following delivery, up to 5 days post-delivery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 50 Micrograms Vaginal Misoprostol (Intervention) | Patient Satisfaction Six Simple Questions, Question 6 | 7 score on a scale |
| 25 Micrograms Vaginal Misoprostol (Control) | Patient Satisfaction Six Simple Questions, Question 6 | 6.5 score on a scale |