## Protocol Section
### Identification Module
**NCT ID:** NCT04891679

**Acronym:** OMS

**Brief Title:** Induction of Labor by Oral Misoprostol Solution

**Official Title:** A Randomised Control Study of Titrated and Static Oral Misoprostol for Induction of Labor at Term

#### Organization Study ID Info
**ID:** Titrated and Static OMS
#### Organization
**Class:** OTHER
**Full Name:** Christian Medical College and Hospital, Ludhiana, India
### Status Module
#### Completion Date
**Date:** 2018-11-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2017-12-01

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2021-05-18
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-13
**Study First Submit QC Date:** 2021-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Christian Medical College and Hospital, Ludhiana, India

#### Responsible Party

**Investigator Affiliation:** Christian Medical College and Hospital, Ludhiana, India

**Investigator Full Name:** Dr. Barbie Sharma

**Investigator Title:** Senior Resident, Department of obstetrics and gynecology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with static-dose oral misoprostol solution for induction of labor at term.

Women with singleton live pregnancy at term without any complications who were admitted in labor room for induction of labor were enrolled.

Study involves allocation of selected women in two groups randomly and use of either titrated or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid induction of labor with oral drug regimen which is easier to comply as compared to vaginal regimens. Women were at risk of all the complications associated with induction of labor like labor abnormalities, risk of cesarean section, non reassuring fetal status.

**Detailed Description:** This comparative randomized study was conducted in the Department of Obstetrics and Gynecology, Christian medical college and hospital, Ludhiana for a period of one year beginning from 1st December, 2017 to 30th November, 2018. The study group comprised of all antenatal women admitted in labor room at term for induction of labor. Informed consent was taken for all selected women. Women were subjected to detailed history taking, a complete physical examination including per vaginum examination (to calculate modified bishop's score and to rule out cephalopelvic disproportion), investigations and a NST. Gestational age was established by the first date of the last menstrual period and confirmed by first trimester ultrasound. Presentation was confirmed by palpation and third trimester ultrasound.

Women after randomization were allocated into two groups. The first group (A) was induced with hourly titrated oral misoprostol regimen and the second group (B) received two hourly static oral misoprostol regimen. Once labor had started, vital signs were closely monitored every 2 hours; fetal heart rate (FHR) and uterine activity every 15 minutes during first stage of labor. Per vaginum examination was done 4-hourly or as indicated.

Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy of titrated and oral misoprstol solution.

### Conditions Module

**Conditions:**

- Induction of Labor

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Single center interventional single-blinded randomised controlled trial

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence. Allocation concealment was carried out by using opaque envelopes that were distributed by the obstetrics nurse. Whereas study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures like timing of oral misoprostol solution doses.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 264

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Titrated oral misoprostol solution

**Intervention Names:**

- Drug: Oral misoprostol solution (OMS)

**Label:** Group A (Titrated OMS)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Static oral misoprostol solution

**Intervention Names:**

- Drug: Oral misoprostol solution (OMS)

**Label:** Group B (Static OMS)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A (Titrated OMS)

- Group B (Static OMS)

**Description:** Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.

Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.

0 hour= 20ml

1. hour= 20ml
2. hour= 30ml
3. hour= 30ml
4. hour= 30ml
5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml

Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

**Name:** Oral misoprostol solution (OMS)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The time taken from induction of labor to delivery measured as

1) \<12 hours 2) 12-24 hours 3) 24-48 hours 4) \>48 hours

**Measure:** Interval between induction and delivery

**Time Frame:** From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days

#### Secondary Outcomes

**Description:** Measured as difference between modified bishop's score before induction of labor and at amniotomy/stopping of oral misoprostol solution regimen; minimum 0f 1 to maximum of 7.

**Measure:** Mean change in modified Bishop's score

**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

**Description:** Measured as 1-2; 3-4; 5-6; 7-8; \>9

**Measure:** Number of misoprostol doses

**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

**Description:** Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours

**Measure:** Time taken to give required doses

**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

**Description:** Measured as \</=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; \>301 mcg

**Measure:** Total misoprostol dosage

**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

**Description:** In terms of Vaginal delivery/LSCS

**Measure:** Mode of delivery

**Time Frame:** Upto 5 days from first dose of oral misoprostol solution

**Description:** Divided into either of the following:

1. SECONDARY ARREST OF DILATATION
2. MSAF IN EARLY LABOR
3. CTG CATEGORY III
4. FAILED INDUCTION
5. CEPHALOPELVIC DISPROPORTION
6. CORD PROLAPSE
7. DEEP TRANSVERSE ARREST
8. ARREST OF DESCENT OF HEAD

**Measure:** Indication for LSCS

**Time Frame:** Upto 5 days from first dose of oral misoprostol solution

**Description:** Required/Not required

**Measure:** Oxytocin augmentation

**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

**Description:** In terms of incidence of either of the following:

1. Incidence of tachysystole
2. Fever- intrapartum and postpartum
3. Puerperal sepsis
4. Uterine rupture

**Measure:** Maternal morbidity

**Time Frame:** From first dose of oral misoprostol solution to dischage from hospital; upto 7 days

**Description:** Measured in terms of incidence of either of the following:

1. Incidence of meconium-stained liquor
2. APGAR scores at 1,5 min
3. NICU stay

**Measure:** Neonatal parameters

**Time Frame:** From childbirth to discharge of the baby; upto 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Singleton live pregnancy;
2. ≥37 weeks gestation;
3. Cephalic presentation;
4. Reassuring fetal heart rate;
5. Modified Bishop'score

Exclusion Criteria:

1. Hypersensitivity to misoprostol;
2. Uterine scar due to previous cesarean section or other uterine surgery;
3. Grand multipara;
4. Multiple gestations;
5. High risk pregnanacies • preeeclampsia with severe features • significant maternal cardiac,renal, liver disease
6. Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage
7. Intrauterine fetal demise

**Gender Based:** True

**Gender Description:** Pregnant females were enrolled for induction of labor in the study.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ludhiana

**Country:** India

**Facility:** Christian Medical College and Hospital

**State:** Punjab

**Zip:** 141008

#### Overall Officials

**Official 1:**

**Affiliation:** Department of obstetrics and gynecology, Christian Medical College and hospital, Ludhiana

**Name:** SUNITA GOYAL, MBBS, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Access Criteria:** Anyone who wishes to access the data for any purpose. Link will be made available at a later date.

**Description:** IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Data will be available beginning immediately and ending 36 months following article publication.

### References Module

#### Available IPDs

**ID:** PATIENT INFORMATION SHEET

**Type:** Informed Consent Form

**URL:** https://figshare.com/s/a6c10a2a4be65f30144b

**ID:** STUDY PROTOCOL

**Type:** Study Protocol

**URL:** https://figshare.com/s/3f978a10eee4e90173bb

#### References

**Citation:** Rouzi AA, Alsahly N, Alamoudi R, Almansouri N, Alsinani N, Alkafy S, Rozzah R, Abduljabbar H. Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor. Am J Obstet Gynecol. 2017 Apr;216(4):405.e1-405.e6. doi: 10.1016/j.ajog.2016.11.1054. Epub 2016 Dec 14.

**PMID:** 27986461

**Citation:** Aduloju OP, Ipinnimo OM, Aduloju T. Oral misoprostol for induction of labor at term: a randomized controlled trial of hourly titrated and 2 hourly static oral misoprostol solution. J Matern Fetal Neonatal Med. 2021 Feb;34(4):493-499. doi: 10.1080/14767058.2019.1610378. Epub 2019 Apr 29.

**PMID:** 31006282

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000020

- Term: Abortifacient Agents, Nonsteroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000010120

- Term: Oxytocics

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M18979

- Name: Misoprostol

- Relevance: HIGH

- As Found: Liquid

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016595

- Term: Misoprostol

### Misc Info Module

- Version Holder: 2024-05-24
